From: Mike Darwin <75120.575@compuserve.com>
Subject: BPI TECH BRIEF #18
Date: 20 Mar 1996

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Date: 19 Mar 96 00:18:15 EST
From: Mike Darwin <75120.575@compuserve.com>
Subject: BPI TECH BRIEF #18

Cryopreservation of CryoCare Patient #C-2150
     by Mike Darwin

     Introduction

     On December 12th, 1995 James Gallagher, a 55-year-old
software developer from Sunset Beach, California, became
CryoCare's first member to enter cryopreservation. He also
became the first patient ever to benefit from new
technologies developed to reduce three forms of injury:
     * pre-mortem shock
     * warm ischemia (the time interval between pronouncement
of death and restoration of adequate blood circulation)
     * cold ischemia experienced during initial blood washout
and cooling, and also during iced-transport from the location
where legal death occurred to the facility where
cryoprotective perfusion is carried out.

     The following is not quite a full technical report, but
neither is it simply a lay-level of summary of key events
without reference to the technical details and the impact
those details had upon this patient's care and potentially,
future patents' care. It is the aim of this report to
include enough quantitative detail that direct comparisons
can be drawn with previous cases. It can be argued that this
is just *one* patient, that solid inferences or statistical
significance cannot be established with n=1. Generally, this
would be true. However, this patient's course is being
compared with many other animals and humans subjected to
similar protocols.

     Using relevant animal models over the last three years,
BioPreservation, Inc. (BPI), the transport and
perfusion/cool-down service provider for this patient, in
conjunction with 21st Century Medicine (21st) has been
evaluating aspects of the protocol used on this patient.
Further, BPI and several of BPI's core technical staff have
had extensive experience applying pre-mortem medication,
transport, and cryoprotective perfusion protocols with
patients from other cryonics organizations in the past, and
also have access to relevant case data from other cryonics
patients whose illness, agonal course, and time to post-
arrest intervention are directly comparable with this
patient's.

     At a minimum, we believe that the close correlation of this
patient's response to that observed in the canine experiments using
the same protocol, and especially when contrasted with results
achieved in comparable human cryopreservation patients treated with
previously used protocols (including a patient treated by
BPI; ACS Patient #9577), is significant. Of particular
importance is this patient's core temperature cooling data,
since cooling is constrained by physical laws which are well
understood, and where the predictability and simplicity of
the system used to carry out cooling allows for little
variation from case to case (where patient mass, body fat
content and distribution, and surface area, are comparable,
of course).

     The significance of other measured parameters in this
case, such as tissue-specific enzyme release (markers of
ischemic injury for specific organs and for the patient as a
whole) and metabolic parameters, is presently more open to
debate. However, even here we believe that the results
achieved with this patient are so different from that
observed in patients with comparable diagnoses and agonal
courses (and in such close agreement with animal data) that
careful consideration should be given to the results.


     Social and Medical Background

     The patient first contacted CryoCare (CC) on 15 July,
1995 to inquire about cryopreservation services. He was
familiar with cryonics due to prior association with a
contract worker whom he employed in the early 1980's who was
heavily involved in cryonics. He had also read cryonics
organizations' literature and met with various cryonics
organization members and personnel (where cryonics was a
topic of discussion) again since the early 1980s. The patient
had been in-touch with several cryonics organizations before
contacting CC, after being informed he was terminally ill.

     Formal communication with CC administration began by e-
mail on 17 July and Mike Darwin, President of BPI was brought
in for a cryonics consult with the patient on 20 July.

     At that time the patient informed BPI that he had been
recently diagnosed with terminal cancer and was interested in
putting cryopreservation arrangements in place. BPI
questioned the patient extensively about his medical history
and treatment and discovered the following relevant
information:

     * The patient did not have health insurance and was
paying for medical care piecemeal as crises or problems
occurred.

     * The patient had not had a definitive diagnosis of
cancer. After more than five months of sacral pain, the
patient had been CT'ed by his family physician, and the
diagnosis was presumptively based on a single CT scan of the
chest and abdomen which revealed numerous solid lesions which
appeared to be tumor, present in the left kidney and
obliterating the left adrenal gland, and also present in the
caudal lobe of the liver, and possibly the descending colon.

     * The patient was seeing an alternative medicine
provider (a biochemist, not a physician) who told him he
probably had primary cancer of the kidney (primary renal
carcinoma) and prescribed a nutrient supplementation regime
coupled with the administration of large doses of urea and
creatinine (waste products of metabolism normally excreted by
the body in the urine) purportedly to stop the spread of the
cancer and convert the cancer cells back to more "normal
morphology." Nutritional supplements of a wide variety but
notably including co-enzyme Q10, vitamin A, beta carotene,
selenium, vitamins E and C, and cesium chloride (13 g/day
cesium chloride ostensibly to stimulate the immune system to
attack and destroy the cancer) were also being administered.

     At this time Mike Darwin refused to accept the patient
as a BPI client until a definitive diagnosis of terminal
illness was established. The patient was told that some
moderately to highly treatable cancers such as non-Hodgkin's
lymphoma may appear indistinguishable on CT from other,
untreatable cancers. It was also noted that on the initial
radiology report (which was read to Darwin) that the
radiologist reading the CT remarked on what he felt might be
a mass in the posterior part of the descending colon, but was
unable to tell with certainty due to the presence of feces in
the bowel. The radiologist listed primary adenocarcinoma of
the colon (the most common type of bowel cancer) as the
number one possibility to rule out.

     Since the patient did not have health insurance, a
variety of options was discussed to determine the nature and
the treatability of the apparent malignant disease. The
patient was referred to BPI's medical consultant Steven B.
Harris, M.D. and the number of options was rapidly pared
down. If it *was* primary renal carcinoma, the only way to
definitively establish that would be to obtain a sample of
the tumor using CT-guided needle biopsy or to do an "open
biopsy" or lapropscopic biopsy wherein surgery is performed
to open or access a body cavity with a trocar and fiberoptic
scope, to inspect and directly obtain a sample of the
questionable tissue.

     Due to the statistically comparatively low likelihood of
primary renal carcinoma in a 55 year-old man (versus the
likelihood of primary adenocarcinoma of the bowel), the
remarks of the radiologist about the possible presence of a
bowel mass on the CT scan, and the absence of health
insurance, it was decided that the most cost-effective and
medically most conservative way to proceed would be to have
the patient undergo fiberoptic colonoscopy (direct
visualization with a flexible fiberoptic viewing device) of
the colon and look to see if there was any tumor present.
(Common things are common; metaphorically the CT was the
equivalent of loud hoof beats in the distance, and when one
hears hoof beats in the Western United States one generally
thinks of horses, not zebras. In this case horses = primary
adenocarcinoma of the bowel).

     A few days later the colonoscopy was performed and our
suspicions were confirmed; there was a large mass nearly
obstructing the descending colon which appeared on visual
inspection to be a malignancy.

     Dr. Harris and Mike Darwin both advised the patient that
bowel obstruction by the rapidly growing tumor was imminent
and that he should consider a palliative colostomy. The
patient was resistant to doing this for several reasons.
First, he had considerable confidence that enemas with urea,
and his alternative cancer treatment regime would at least
shrink the tumor (he was receiving considerable encouragement
from his alternative care provider in this regard), so that
surgery could be avoided. Secondly, the anticipated cost of
a colostomy and associated care would jeopardize the funding
the patient had set aside from his savings for
cryopreservation.

     This created a new and difficult ethical problem for
both BPI and CC. Clearly CC needed to maintain its funding
minimums at a level sufficient to provide reasonable safety
margins for continued cryogenic care of the patient. And,
clearly, BPI is not in the charity business and has staff to
pay and marginal costs to address. On the other hand, it is
hardly tenable to confront a patient with the choice between
foregoing cryopreservation or facing a gruesome and agonizing
death from an obstructed bowel (months earlier than would be
the case if colostomy or colectomy were performed)

     Since this patient was low on funds already (nearly
$50,000 of savings having been spent on piecemeal alternative
"medical" care) he had already agreed to the use of new
procedures and to the biopsying of his brain in exchange for
reducing the basic cost of BPI's procedures. Confronted with
this new situation, BPI reduced its charge to below the
break-even level and the patient volunteered to cooperate
with what then constituted extraordinary antemortem
monitoring.

     This was the first time BPI, CC, or, to our knowledge,
any cryonics organization has been faced with a situation
where a patient (and his cryonics organizations) was
confronted with a choice between reasonable standard of care
(avoiding a serious, life shortening, and definitely quality-
of-life reducing complication of the illness), and being
cryopreserved. This was deeply disturbing for all involved,
and merits intense discussion in the immediate future, not
just by CC and BPI, but by the cryonics community as a whole.
While it is inappropriate to belabor this point here, this
case points up that increasingly cryonics organizations will
be dealing with both members and non-members who have no
health insurance (not even HMO coverage), no access to
government healthcare such Medicaid, Medicare or VA care,
and/or who have limited access to health care with HMO, PSO,
PPO or other care which forces them to make major quality of
life or length of life decisions based on use of their non-
healthcare allocated funds such as savings, property equity,
and even accumulated cash value or resale value of life
insurance policies--including those specifically earmarked
for cryonics.

     Further, in some cases the state, acting through the
courts, may appropriate these assets at the request of
guardians or relatives. The issues raised by the
inevitability of a massive restructuring of health care cost
and availability in the United States which is occurring now,
should be considered now. This case should serve as a
sentinel in this respect.

     A few days after his colonoscopy, the patient began to
experience symptoms of bowel obstruction (increased anorexia,
nausea, shot-gun pellet stool, vomiting and abdominal
distention), and so a double-barreled colostomy was performed
on 29 July. This procedure was uneventful and the patient
returned home where he was cared for by his sister, his
brother-in-law and his nephew. The patient continued with
his alternative medicine regime, although, due to increasing
nausea, he abandoned use of the cesium chloride.

     At this point BPI became disengaged from close
involvement with the case over issues related to funding
details. This was an issue between the patient and CC, and
until the patient became a fully signed-up CC
cryopreservation member, it was inappropriate for BPI to be
as closely involved.

     As financial negotiations proceeded favorably, BPI again
became involved and made a home visit on 15 October with
medical advisor Dr. Harris and BPI staff members Carlotta
Pengelley, LVN, Joan O'Farrell, Sandra Russell, and Mike
Darwin also present. The purpose of this visit was to
evaluate the home for logistics of access (it was a second-
story apartment with outside stair-access only) and equipment
set-up, meet the family and prepare them for the reality of
transport, assure the patient's medical and pain control
needs were being met, encourage the patient to enroll in home
hospice, and to carefully medically examine the patient in
order to determine "staging" or likely time-course to legal
death for cryonics reasons.

     Dr. Harris examined the patient thoroughly during this
visit and baseline blood chemistries were drawn, including
samples collected, spun-down and frozen to dry ice
temperature on-site for subsequent baseline antioxidant and
lactate levels (the former to be done by Pantox Labs of San
Diego, CA) as well as for a routine chemistry panel an a
screening for infectious diseases.

     During this visit Dr. Harris noted that the patient had
right leg weakness (barely noticeable) a right visual field
cut (right homonymous hemianopia), nausea and anorexia (lack
of appetite) and that he weighed 73.1 kg down from a previous
healthy weight of 86-88 kg. Careful history taking also
disclosed recent (2 weeks duration) inability to read, which
the patient attributed to lack of ability to concentrate, and
urinary incontinence. The patient was noted to have cancer
wasting syndrome and complained of severe back pain of eight
months duration. Further, Dr. Harris felt it very likely the
now nearly immobilizing back pain (the patient was
constrained to lie face down on a specially modified cot most
of the time) was due to involvement of the sacrum with
metastatic disease.

     Dr. Harris' presumptive diagnoses at the conclusion of
the home visit were probable large metastases (4-6 cm) of the
primary colon cancer to the left occipital lobe of the brain
which was likely responsible for the right-sided visual field
cut, weakness, and incontinence. Probable metastatic
involvement of the sacrum was assumed, with resulting
uncontrolled bone pain. Further presumptive diagnoses were
tumor necrosis factor (TNF) and related cytokine cancer
wasting syndrome, and poor nutritional status (calorie count
estimated at 1500 kcal/day or less). The family was urged to
take the patient to an imaging center and have an MRI or CT
of the head done to rule out malignant involvement of the
brain (the patient's family was informed of the high
probability of the metastasis, but the patient at this time
was not).

     A CT scan with and without contrast was performed on 17
October and a 6cm mass was indeed found in the left occipital
lobe of the brain. Dr. Harris, in conjunction with the
patient's newly acquired primary care physician persuaded the
patient that it was imperative that he undergo palliative
radiotherapy to his head and to his sacrum (lower back). The
patient was resistant to undergoing this treatment because of
his disdain for "radiation treatment of cancer" and because
of his concerns about possible damage to his brain from the
radiation which might compromise his chances for good
cryopreservation.

     Dr. Harris was instrumental in convincing the patient to
get palliative radiation treatment. He explained that
failure to do so would result in hemiplegia (paralysis on one
side) possible loss of speech, complete incontinence of
bladder and stool, and likely death from elevated
intracranial pressure which might very likely expose his
higher brain to extended periods of periods of minimal or
absent blood flow (ischemia) for hours prior to cardio-
respiratory arrest and pronouncement of legal death. The
consequences of unchecked growth of an aggressive malignant
tumor in the brain, versus the by comparison trivial effect
of palliative radiotherapy (increased sleepiness and
fatigue, hair loss and modest compromise of short-term
memory) were emphasized.

     (In cases of metastatic brain disease the entire brain
is usually radiated both to hold down the costs associated
with shielding and selective irradiation of the tumor, and,
more importantly, to "head off" the proliferation of other
metastases; where you see one seed sprouting there are likely
other to be others germinating. Whole brain irradiation
decreases the likelihood of secondary tumors developing in a
patient who is terminal with aggressive malignant disease).

     The patient had previously been scheduled to have a
chronic intrathecal line placed into his lumbar spine for
delivery of chronic intrathecal morphine by pump for chronic
pain control, and on 16 October, this was done. Within 48
hours, however, the patient was unable to walk, and was
admitted to the hospital. There, neurological exam showed
profound bilateral leg weakness and normal spinal fluid. X-
rays also showed a metastatic lytic lesion to the right
sacrum, with possible nerve compression to the right leg.
The neurologist examining the patient for the first time
thought that the new weakness was due to cauda-equina
compression syndrome from tumor; and rejected the idea, put
forth by Dr. Harris, that the very rapid onset of weakness
coupled with the relationship to the intrathecal line
placement, made that procedure suspect. Dr. Harris, however,
was able to convince the patient's primary physician of this
possibility, and the intrathecal morphine was discontinued.
Within a day the patient recovered use of his legs, but a
definitive diagnosis of the problem was never made. He
continued for the rest of his course, however, on morphine
delivered via peripheral line.

     During hospitalization for the leg problem, the patient
was seen by a radiotherapist, and radiotreatment to his brain
and sacrum was initiated. In particular, he underwent 10
fractionated doses of palliative radiotherapy to his head,
with 4,000 rads (cGy) to the whole brain and a 10,000 rad
boost to the tumor.

     The patient was also enrolled in a good Home Hospice
program which did much to help the family by providing basic
care advice and improved pain management.

     Financial negotiations between the patient, the
patient's representative family member and CC continued (with
some last-minute input from BPI) and the patient became a
fully funded CC cryopreservation member on 7 November, 1995.

     On 5 November the patient spoke with Dr. Harris by phone
and reported himself as being very depressed and wishing to
withdraw from the program of anti-TNF and immune stimulating
drugs the patient had been started on after the withdrawal of
the alternative medicine practitioner. Dr. Harris noted that
the patient sounded sort of breath (dyspneic) on the phone
and asked the patient if he was, which the patient denied.

     That evening the patient was transported to the
emergency department (ED) of a nearby hospital acutely short
of breath and panicky with air hunger. The paramedics who
carried out the transport noted that the patient had
diminished breath sounds on the right side nearly to the base
of the right lung, and began oxygen at 2 liters per minute
(LPM) during transport. When the patient was examined in the
ED the ED physician said he could find no diminished breath
sounds, stopped the oxygen, waited "a few minutes," noted the
patient's oxygen saturation by pulse oximetry was 96%, and
told him to go home. At that point Dr. Harris spoke with the
ED physician and requested that arterial blood gases be drawn
and a chest X-ray be taken. This was a medically sound
request for several reasons: first, it would help establish
the basis of the patient's shortness of breath and determine
if palliative oxygen therapy should be considered to reduce
or eliminate "air hunger." Or, failing relief of air hunger
with oxygen supplementation, increase the degree of sedation
to make the patient more comfortable. Second, from a cryonics
standpoint it was important to know if the patient was
experiencing a complication or exacerbation of the primary
disease (such as pneumonia; a big risk here since the brain
tumor required immunosuppressively high doses of
dexamethasone to control intracranial pressure) which would
justify deployment of the standby team.

     The ED physician politely but firmly brushed off Dr. Harris'
request (even though the patient was willing to pay for the
requested tests in cash) and sent the patient home. During the
trip home the patient again became acutely dyspneic and spent the
night miserable and panicky with air hunger.

     The next morning the patient's HMO waiting period was up
(he had HMO coverage available regardless of pre-existing
illness, but only after a waiting period) and the patient was
again transported by ambulance, this time to the office of
the internist employed by the HMO. The physician lifted the
blanket, looked at the patient, informed the patient that
"pneumonia was the cancer patient's friend," further informed
the patient that he had end-stage cancer, and sent the
patient home, *again without oxygen*. At this point Dr.
Harris intervened and arranged for palliative oxygen therapy
in conjunction with the patient's private physician.

     The following weeks saw an up and down course for the
patient. The radiotherapy restored his vision and ability to
work initially, and he experienced much less bone pain.
(Prior to this time the patient had worked as a consulting
programmer on a part-time basis as his illness had
permitted.) However, he continued to lose weight and
eventually began to experience intermittent but progressive
dyspnea, constant nausea with occasional vomiting, and
exogenous depression associated with clearly deteriorating
quality of life. Finally, he became unable to work once
again. The patient was now receiving more or less continuous
IV morphine administered peripherally through a strap-on
battery-operated pump.

     The day after Thanksgiving, 24 November, a second home
visit by BPI staff (without Dr. Harris) was carried out for
the purpose of collecting baseline cerebral functioning
monitoring (CFM) data and evaluating the patient's condition
first hand. The patient was noted to appear slightly more
wasted, to be largely oxygen dependent, but to have well
managed pain and to be ambulatory for hygiene, and limited
socialization. Baseline EKG and CFM data were collected and
the patient's feelings and thoughts about cryopreservation,
and his informed consent were videotaped.

     An unfortunate and unexpected sequelae to this visit was
that one of the BPI team members was infected with influenza
A and unaware of it at the time of the visit. Within 48 hours
of the visit the patient was febrile (39 degrees C), severely
dyspneic, and suffering profound malaise and myalgia. The
patient called BPI to report he was ill and the hospice nurse
was called in to evaluate breath sounds and consult with
BPI's medical advisor (Harris). The hospice nurse reported no
change in breath sounds, no cough and no evidence of
pneumonia, but rather a febrile illness with myalgia
consistent with the flu.

     It was explained to the patient that he probably had
early influenza (onset of symptoms was that AM) and that this
could probably be treated with combination anti viral drugs
and an antibiotic to protect against secondary infection.
Alternatively, the patient was told he could elect to refuse
treatment which would carry with it the likelihood of death
from pneumonia or some other inter-current infection. These
choices were reviewed with the patient because of the
patient's prior, repeatedly stated desire to refuse further
life-extending care, including refusal to see a pulmonologist
and oncologist to evaluate the cause of the dyspnea and
perhaps treat it, if it was secondary to tumor-related
compression of a large bronchus. (Such treatment can be
simply carried out with additional localized radiotherapy, or
even laser ablation of tumor growing into a bronchus.)

     The patient decided to accept treatment for the
influenza infection and was started on p.o. (oral) ribavirin
400 mg q. 8 hours, and 100 mg b.i.d. rimantidine, an
antiviral specific for influenza A. Antibiotic prophylaxis
for secondary infection was instituted with doxycycline 100
mg b.i.d.

     There was prompt improvement in symptoms and signs of
the illness with the patient becoming afebrile in less than
24 hours from the start of treatment with antivirals and
antibiotic.

     During the closing days of November the patient
experienced the typical interleaving of relatively "good"
days with progressively worse and more frequent "bad " days.
The patient's p.o. medications at this time were:

     aspirin 1.25 grain, p.o., daily
     co-enzyme Q10, 100 mg p.o. t.i.d.
     dexamethasone, 4 mg t.i.d.
     doxycycline, 100 mg, b.i.d.
     d-alpha tocopherol, 1,000 I.U., t.i.d.
     ascorbic acid, 1 g t.i.d.
     phenytoin (Parke Davis), 300 mg q.d.
     morphine sulfate by IV pump p.r.n. for pain.
     50 mg thalidomide, p.o. before retiring
     10 mg melatonin, p.o. before retiring

END OF PART OF BPI TECH BRIEF #18

From: Mike Darwin <75120.575@compuserve.com>
Subject: BPI TECH BRIEF #18, Part II
Date: 20 Mar 1996

    ---- CryoNet Message Auto-Forwarded by <kqb@cryonet.org> ----

Date: 20 Mar 96 00:50:41 EST
From: Mike Darwin <75120.575@compuserve.com>
Subject: BPI TECH BRIEF #18, Part II

Cryopreservation of CryoCare Patient #C-2150, Part II
     by Mike Darwin

     Decision to Terminate Life Support

     At the beginning of December the patient became
increasingly oxygen dependent and began experiencing a return
of visual disturbances which were prodromal to his prior
homonymous hemianopia. He also experienced a return of
urinary incontinence. The patient expressed justifiable
concern that the original brain metastases, or another, was
again beginning to cause problems, or that structures
adjacent to the tumor were experiencing the un-typical
delayed death as a result of the high dose radiation to which
they were exposed.

     Further, the nausea which had been present since shortly
after the illness was diagnosed was now more or less constant
with occasional vomiting. Attempts at pharmacologic control
of the nausea using hydroxyzine, chlorpromazine, compazine,
ginger, and tetrahydrocannabinol (THC) were unsuccessful.

     During the first days of December the patient repeatedly
contacted BPI and expressed a desire to withdraw from
palliative oxygen and to abruptly stop steroids and "get it
over with." He explained that his quality of life was no
longer acceptable, and that he wished to take action to end
his life in a legal manner before the quality deteriorated
further, and especially before he became unable to exercise
choice in the matter.

     Unfortunately, while the patient had responded well to
prompt anti-viral therapy for influenza, two of the team
members were ill with the flu and with the non-bacterial
bronchitis which accompanied it. Complicating matters further
was the illness (again with the flu) of one of the team
members' two small children. The patient was told that while
we would respond if he was set upon immediate implementation
of this course of action, optimum response would best be had
by delaying a week or so longer in order to give team members
time to recover and to permit final set-up of equipment in
the home and last minute preparations to be made.

     When staff were largely recovered, a window of time was
agreed for discontinuation of life support. The patient's
private primary care physician (not involved with BPI) was
closely involved in this decision, and advised BPI that he
felt withdrawal of oxygen would result in rapid
decompensation and cardiovascular collapse. He said he felt
the patient was making an informed and "rational" choice
(i.e., he saw no indication of compromising psychiatric
illness, organic brain disorder, or undue influence). The
physician commented that he was comfortable with the
patient's decision since the patient had repeatedly told him
he would have withdrawn from life support far earlier had it
not been for his cryopreservation arrangements. The physician
expressed a willingness to be present when the patient
discontinued life support and to pronounce legal death.
Further, the physician ordered that a Hickman catheter be
implanted in the patient to facilitate administration of pain
medication (his peripheral veins were "exhausted" from
repeated sticks and catheter placement). BPI requested that
the catheter be a large-bore Hickman to facilitate rapid, low
resistance of transport medications, and the physician agreed
to this request.

     During the weekend of 9-10 December the patient's home
was fully prepared for standby and transport. The Mobile
Advanced Life Support System (MALSS) was set up in the living
room and the extracorporeal circuit strung. An operating room
light was put in place, back tables were set up and
instrument trays and ancillary supplies were laid out and
readied. Specialized monitoring equipment for blood
pressure, cerebral function, pulse oximetry, and acute lab
collection (blood gases) was also put in place. The CDI
point-of-care in-line blood gas system was also set up next
the MALSS and the monitoring cells cut into the arterial and
venous lines of the extracorporeal circuit to allow for
continuous acquisition of blood gas data during initial
bypass-assisted cooling, and during blood washout and
replacement with 21CMBP-002 flush-store solution.

     The patient's physician was then consulted about the
possibility of administering pre-cryopreservation medications
to reduce the insult from the agonal hypoperfusion/hypoxia
and post-pronouncement ischemia which would necessarily occur
prior to mechanical restoration of circulation and breathing
during transport by BPI. The physician reviewed the
medications suggested and agreed to prescribe all those
available in the U.S. and Mexico. The patient had made
arrangements through an AIDS buyers' club to obtain other
medications which he believed would be efficacious in helping
to ameliorate ischemic injury. These were largely drugs
which 21st Century Medicine animal research had shown to be
cerebro-protective if given before the ischemic insult.

     The following schedule of pre-cryopreservation
medication was begun by the patient on 10 December, 1995:

     Medications for 10 December:

     aspirin, 1.25 grain, p.o., daily
     ascorbic acid, 1 g t.i.d.
     N-t-butyl-a-phenylnitrone, 500 mg, p.o. with evening meal
     sodium selenite, 1000 mcg selenium p.o.
     co-enzyme Q10, 100 mg p.o. t.i.d.
     dexamethasone, 4 mg p.o. t.i.d.
     doxycycline, 100 mg p.o.
     d-alpha tocopherol, 1,000 IU, t.i.d.
     phenytoin (Parke Davis), 100 mg, t.i.d.
     morphine sulfate by IV pump p.r.n. for pain.
     50 mg thalidomide, p.o. before retiring
     10 mg melatonin, p.o. before retiring

     Medications for 11 December:

     aspirin, 1.25 grain, p.o., daily
     ascorbic acid, 1 g t.i.d.
     piracetam 800 mg p.o. at 10:00
     N-t-butyl-a-phenylnitrone, 1g mg, p.o. with evening meal
     sodium selenite, 1000 mcg selenium p.o.
     co-enzyme Q10, 100 mg p.o. t.i.d.
     dexamethasone, 4 mg t.i.d.
     doxycycline, 100 mg, t.i.d.
     d-alpha tocopherol, 1,000 IU , t.i.d.
     phenytoin (Parke Davis), 100 mg, t.i.d.
     morphine sulfate by IV pump p.r.n. for pain.
     50 mg thalidomide, p.o. before retiring
     10 mg melatonin, p.o. before retiring

     Patient agreed to take no solid food after 11 December at 2400
since it was his decision to withdraw life support the following
afternoon.

     Medications for 12 December:

     aspirin, 1.25 grain, p.o., daily
     ascorbic acid, 1 g t.i.d.
     N-t-butyl-a-phenylnitrone, 1 g, p.o. with evening meal
     sodium selenite, 1000 mcg p.o.
     co-enzyme Q10, 100 mg p.o. t.i.d.
     dexamethasone, 4 mg t.i.d.
     doxycycline, 100 mg , t.i.d.
     d-alpha tocopherol, 1,000 IU , t.i.d.
     phenytoin (Parke Davis), 100 mg, at 100 and 1600
     morphine sulfate by IV pump p.r.n. for pain.
     misoprostol, 100 micrograms at 1600
     melatonin, 50 mg, p.o. at 1900
     prilosec, 20 mg, p.o. at 1900
     800 mg ibuprofen at 1900
     phenytoin, 500 mg, p.o. at 1900
     Maalox, 60 cc p.o. immediately before discontinuing oxygen.

     The patient obtained on his own, and self-administered
without assistance at about 2100 through his implanted
Hickman catheter, 250 cc of Dextran 40 in normal saline
(Baxter, Irvine, CA) containing 1 mg of Nimodipine (A.G.
Bayer, Germany), 40,000 IU of sodium heparin and 5 grams of a
proprietary agent developed by 21st Century Medicine.
     This latter agent will be hereinafter referred to as
21CM-006; it was developed to protect against ischemic
injury, up-regulate the efficacy of anaerobic metabolism, and
ameliorate V/Q mismatch (where blood flows through
unventilated area of lung and thus does not get oxygenated)
and prevent loss off normal vasomotion (where blood delivered
to the tissues is not distributed to the capillaries properly
resulting in "shunting" and failure of delivery of oxygen and
nutrients to the tissues in shock) concurrent with
discontinuing high flow oxygen support (8-10 LPM by mask with
reservoir bag: FIO2 was ca. 80-90%).

     A final conversation was had with the patient at about
1900 at which time he was repeatedly advised that he could
change his mind without any problem to BPI and that he should
feel no pressure to pursue this course of action. His
response was: "You don't understand. This is easy. The hard
thing would be taking one more day of life like this." The
patient appeared in good spirits and laughed and joked with
family and team members. He explained that he had accepted
he was either to die or recover from cryopreservation, and
that either way he was fully prepared and psychologically
ready. He had played a card game with family and friends
that afternoon, and explained that while he was a little
apprehensive, he intended to take some alprazolam (Xanax) and
get ready for the journey ahead.

     Several BPI team members spoke with the patient
privately and said their good-byes.


     Cardiopulmonary Arrest

     At the request of the patient and his family (for
reasons of intimacy; saying farewells etc., and basic
privacy) the entire BPI team withdrew to the BPI transport
vehicle parked outside the patient's apartment. The
patient's attending and primary care physician remained with
the patient and the patient's family to supervise withdrawal
of life support, assure adequate palliation of air hunger and
discomfort, and promptly pronounce legal death. BPI
personnel were to be summoned immediately after pronouncement
by cell phone (four BPI personnel had cell phones!).

     At approximately 22:50, the patient discontinued oxygen.
He had taken approximately 3 mg of alprazolam about an hour
before discontinuing oxygen, and he had access to self-
administered morphine (pump limited boluses) to ease air
hunger.

     It was reported that the patient rapidly lost
consciousness on withdrawal of oxygen and experienced
cardiopulmonary arrest at 2311 on 12 December, 1995.


     Transport Phase 1: CPR, Medication, External, Initial
Cooling

     Intubation was accomplished at 23:13 by Dr. Harris, and
"Active Compression-Decompression-High-Impulse CPR" (ACDC-
HICPR), using a custom built Michigan Instruments "Thumper"
mechanical chest compressor, was initiated at 23:14. A
standard Ambu ACDC silastic suction cup was used on the
Thumper to achieve the ACDC component of the ACDC-HICPR.
Placement of a tympanic temperature probe was achieved
concurrent with intubation (during securing of the
endotracheal tube). The initial tympanic temperature reading
was 36.8 degrees C.

     Tympanic (eardrum) temperatures were used in this
patient because it is well established that tympanic
temperature reflects true brain temperature since the blood
supply for the eardrum and midrain and cerebral cortex are
the same. Typmanic temperature is thus a much more reliable
measure of the temperature of the iorgan we are *most*
interested in preserving (the brain) than are esophageal or
rectal temperatures. Further, work with dogs at 21st has
established a far closer correlation between tympanic
temperature and actual measured brain temperature (via
invasive probes) than esophageal or rectal temperatures

     Family and friends had begun icing the patient at the
time of pronouncement (legs, abdomen and lower thorax;
leaving the head unencumbered so that airway management could
be instituted before icing) and the head, thorax and axilla
were iced concurrent with the start of cardiopulmonary
support.

     Simultaneous with the start of external cooling, a
Darwin rectal thermocouple probe was placed in the descending
leg of the double barreled colostomy and the 60 cc balloon
inflated to anchor it in place. A Darwin colonic lavage tube
with a 60 cc silastic balloon and fenestrated tip was also
inserted in the stoma of the ascending end of the colostomy,
and the balloon on the lavage tube was also inflated to
anchor it into the ascending colon.

     Immediately thereafter a stab wound was made (using
sterile technique) through the medial aspect of the right
external oblique muscle 3 cm to the right of the navel, at
the level of the iliac crest. The stab wound was rapidly
extended in depth by blunt dissection with Metzenbaum
scissors (Mets) until the peritoneum was reached, and a 1 cm
incision was made in the peritoneum with Mets and a Darwin
peritoneal lavage tube was inserted and its 60 cc silastic
balloon rapidly inflated to seal and anchor it in place.

     Once all lavage tubes were in place the patient's
ascending, transverse colon, and terminal ileum were
irrigated with 2 liters of iced Normosol-R, pH 7.4, and the
peritoneal cavity was irrigated with 4 more liters of this
solution (Abbott Pharmaceuticals, Chicago, IL). Reservoirs
connected to the colonic and peritoneal lavage tubes were
placed on the floor and the lavage fluid was allowed to drain
into the respective bags by gravity.

     The first pulse oximetry and end-tidal CO2 readings were
obtained at 23:16 and were 95% and 5% respectively. Wave form
acquisition on the pulse oximeter was excellent and the pulse
rate of 80 per minute correlated exactly with the action of
the Thumper. At 23:19 the patient's tympanic and descending
colon temperatures had declined to 29.8 degrees C. By 23:20
the descending colon temperature had rebounded to 34 degrees
C. At 23:21 the peritoneum was lavaged with 2 additional
liters of iced Normosol. At 23:22 the tympanic temperature
was 28.7 degrees C and the descending colon temperature was
28.6 degrees C. Oxygen saturation at that time was 93%, and
End tidal CO2 (EtCO2) was 4%.

     Administration of Transport Medications began at 23:12
and was as follows:

     Epinephrine 12.6 mg, 23:12, IV push (given to support
blood pressure during CPR).

     The drug 21CM-005 3.15 g, IV push, 23:16, (This drug is
a proprietary compound given to inhibit lactic acidosis and
increase the efficacy of anaerobic metabolism). 3.15 g of
21CM-005 contains approximately 40 mEq of potassium, an
amount sufficient to preclude restoration of spontaneous
cardiac activity.

     Soporate (21CM-004) 6.30 g IV push, 23:12 (Soporate is a
proprietary compound given to inhibit excito-toxicity in a
class of brain receptors found to be critical in mediating
cerebral re-perfusion injury in dogs following 12+ minutes of
global cerebral ischemia using a cardiac arrest model. The
drug also acts as a general anesthetic preventing patient's
from regaining consciousness during cardiopulmonary support.)

     21CM-005 6.30 g IV push, 23:12 (see above for
explanation of the pharmacology of this agent).

     Oxynil (21CM-003) 630 mg IV push, 23:13 (Oxynil is a
proprietary agent which has been shown to ameliorate brain
ischemia in dogs by its free radical trapping ability. It is
useful primarily as an adjunct and potentiator of other
antioxidant medications).

     21CM-002 100 ml; 50 ml IV push, 50 ml over ca. 10
minutes. Push dose given at 23:15, infusion completed at
23:28. (21CM-002 is a cremophor emulsion (micellized)
mixture of two proprietary antioxidants which rapidly cross
the blood brain barrier. One of these antioxidants crosses
mitochondrial membranes rapidly and prevents failure of high
energy metabolism in neuron and glial cells following re-
perfusion after global ischemic injury in dogs of 12+ minutes
duration).

     Deferoxamine 2g was added to the mannitol infusion (126
g mannitol as 20% solution in water). Mannitol infusion was
begun at 23:32 and concluded at 23:40.

     Exiquell (21CM-005) 315 mg IV push. (Exiquell is a
proprietary agent used to inhibit the quaint-quisqualate
receptor system which is a significant source of excito-
toxicity following global cerebral ischemia in the dog.)

     THAM (tromethamine) 15.75 g in 250 cc (50 cc IV push),
with the balance by IV infusion, 23:18

     Mannitol (see Deferoxamine above).

     Pavulon (pancuronium bromide) 2 mg, 23:16, to inhibit
shivering and prevent return of spontaneous respiration.

     Methylprednisolone 1 g IV infusion over a minimum of 5
minutes, begun 23:16, ended, 23:20.

     Cipro IV (ciprofloxacin; antibiotic causing no cold
agglutination) 400 mg IV infusion given slowly between 23:16
and 23:30.

     Dextran 40 (Gentran) in 10% saline, 500 cc.

     Administration of all transport medications to this
patient was completed at 23:40.

     The first blood sample for gases, chemistries and
electrolytes could not be collected until after the
conclusion of medication administration. A central venous
sample was collected via the patient's Hickman line at 23:50
on 13 December and yielded the following results:

     RESULTS:	NORMAL RANGES

Tympanic Temperature: 25.7 degrees C, Descending Colon
Temperature 19.0 degrees C

     pH	7.34	7.35 (mean)
     pCO2	52.4 mmHg	45-55
     pO2	37.0 mmHg	40-50
     O2 Sat	89%	70-75
     BUN	15.0 mg/dl	7-25
     Creatinine	1.1 mg/dl	0.7-1.4
     Sodium	120 mEq/l	135-146
     Potassium	5.5 mEq/l	3.5-5.3
     Chloride	82 mEq/l	95-108
     Magnesium	1.7 mEq/l	1.2-2.0
     Calcium	7.2 mg/dl	8.5-10.3
     Phosphorus	7.8 mg/dl	2.4-4.5
     Protein, Total	5.8 g/dl	6.0-8.5
     Glucose	251 mg/dl	70-125
     Bilirubin,Total	0.8 mg/dl	0.0-1.3
     Alk Phosphatase	76 U/L	20-125
     LDH, Total	227 U/L	0-250
     GGT	58 U/L	0-65
     AST	101 U/L	0-42
     ALT	69 U/L	0-48
     Uric Acid	0.5 mg/dl	4.0-8.5
     Iron, Total	138 mcg/dl	25-170
     Iron Binding Capacity	748 mcg/dl	200-450
     % Saturation	18	12-57
     HCT	26%	41-50

     The next central venous blood sample collected during CPR at 0020
on 13 December, yielded the following results:

     Tympanic Temperature: 23.0 degrees C, Descending Colon
Temperature13.8 degrees C

     pH	7.115	7.35 (mean)
     pCO2	27.8 mmHg	45-55
     pO2	35.1 mmHg	40-50
     O2 Sat	88%	70-75
     BUN	17.0 mg/dl	7-25
     Creatinine	1.1 mg/dl	0.7-1.4
     Sodium	132 mEq/l	135-146
     Potassium	4.3 mEq/l	3.5-5.3
     Chloride	91 mEq/l	95-108
     Magnesium	1.8 mEq/l	1.2-2.0
     Calcium	7.8 mg/dl	8.5-10.3
     Phosphorus	9.9 mg/dl	2.4-4.5
     Protein, Total	3.4 g/dl	6.0-8.5
     Glucose	300 mg/dl	70-125
     Bilirubin, Total	1.1 mg/dl	0.0-1.3
     Alkaline Phosphatase	92 U/L	20-125
     LDH, Total	376U/L	0-250
     GGT	69 U/L	0-65
     AST	182 U/L	0-42
     ALT	126 U/L	0-48
     Uric Acid	0.5 mg/dl	4.0-8.5
     Iron, Total	177 mcg/dl	25-170
     Iron Binding Capacity	779 mcg/dl	200-450
     % Saturation	18	12-57
     HCT	26	41-50

     At 0050 another central venous sample was collected from the
Hickman catheter and revealed the following results:

     Tympanic Temperature: 21. degrees C, Descending Colon
Temperature 9.9 degrees C

     pH	7.087	7.35 (mean)
     pCO2	25.2 mmHg	45-55
     pO2	39.2 mmHg	40-50
     O2 Sat	91%	70-75
     BUN	17.0 mg/dl	7-25
     Creatinine	1.0 mg/dl	0.7-1.4
     Sodium	134 mEq/l	135-146
     Potassium	4.9 mEq/l	3.5-5.3
     Chloride	91 mEq/l	95-108
     Magnesium	1.9 mEq/l	1.2-2.0
     Calcium	7.9 mg/dl	8.5-10.3
     Phosphorus	10.6 mg/dl	2.4-4.5
     Protein, Total	3.5 g/dl	6.0-8.5
     Glucose	308 mg/dl	70-125
     Bilirubin, Total	1.1 mg/dl	0.0-1.3
     Alkaline Phosphatase	91 U/L	20-125
     LDH, Total	366 U/L	0-250
     GGT	69 U/L	0-65
     AST	204 U/L	0-42
     ALT	140 U/L	0-48
     Uric Acid	0.5 mg/dl	4.0-8.5
     Iron, Total	179 mcg/dl	25-170
     Iron Binding Capacity	778 mcg/dl	200-450
     % Saturation	23	12-57
     HCT	26	41-50

     The final central venous sample taken during CPR was at
01:20 on 13 December and yielded the following results:

     Tympanic Temperature: 19.3. C, Descending Colon
Temperature 7.5 degrees C

     pH	7.047	7.35 (mean)
     pCO2	23.7 mmHg	45-55
     pO2	110.4mmHg	40-50
     O2 Sat	98.1%	70-75
     BUN	17.0 mg/dl	7-25
     Creatinine	1.0 mg/dl	0.7-1.4
     Sodium	133 mEq/l	135-146
     Potassium	5.7mEq/l	3.5-5.3
     Chloride	92 mEq/l	95-108
     Magnesium	1.9 mEq/l	1.2-2.0
     Calcium	7.9 mg/dl	8.5-10.3
     Phosphorus	11.3 mg/dl	2.4-4.5
     Protein, Total	3.5 g/dl	6.0-8.5
     Glucose	364 mg/dl	70-125
     Bilirubin, Total	1.2 mg/dl	0.0-1.3
     Alkaline Phosphatase	92 U/L	20-125
     LDH, Total	380 U/L	0-250
     GGT	69 U/L	0-65
     AST	214 U/L	0-42
     ALT	148 U/L	0-48
     Uric Acid	0.5 mg/dl	4.0-8.5
     Iron, Total	178 mcg/dl	25-170
     Iron Binding Capacity	777 mcg/dl	200-450
     % Saturation	23	12-57
     HCT	22	41-50


     Intermim Interpretation and Comment On Cooling

     From the laboratory and temperature data above, several
important conclusions can be drawn, particularly when taken
in the context of the protocol used in this case, in
comparison with results obtained in two previous cases which
compare with this one closely (Alcor patient A-1260, and ACS
patient 9577).

     Direct comparisons of many of the parameters in these two cases is
not possible owning to absence of data in the previous cases. For
instance, in patient A-1260 no temperature data was acquired until
32 minutes after cardiac arrest. Thus, a direct comparison between
cooling rates during (say) the critical first 10 minutes post
arrest is not possible here. However, comparisons can still be
made where data does exist at corresponding intervals.

     These three patients are of particular interest to compare because
they match each other closely in sex, weight, fat
distribution, and body surface areas, and they are of
reasonably close ages. All patients were cooled at a minimum
using a portable ice bath and ice-water circulating
pump/distribution assembly (two with identical equipment).
All patients had cooling and CPR begun within 2-4 minutes of
cardiopulmonary arrest, and all were promptly medicated using
the specified protocol. It is also important to note that all
patients died of illnesses, two of AIDS and one of
disseminated cancer, which left them cachectic and which
involved compromise to multiple organ systems. One notable
difference was the prolonged agonal course of ACS-9577
compared to the other two patients, and the poor response to
cardiopulmonary support this patient exhibited, probably as a
result of the antemortem ischemic injury and pulmonary
compromise.

     Data from one other patient, A-1049, a 32.8 kg severely wasted
patient who arrested from dehydration secondary to end-stage
adenocarcinoma of the lung, is also relevant. This patient is
included since her mass and fat content/distribution and
response to cardiopulmonary support were the most favorable
of any patient cryopreserved by comparable methods available
to this author. This patient thus serves as "best-case" for
the efficacy of previously used methods of cooling,
medication and CPR.

     The number of asterisks after the case number indicates
the overall score, from zero to ****, for response to
cardiopulmonary support as evaluated by EtCO2, skin-color,
femoral pulse, and other parameters when available.

     A critical determining factor in how well a patient will
cool during transport in addition to surface area, mass and
fat quantity and distribution (fat is a good insulator) is
the adequacy of blood circulation. Warm blood being delivered
to the surface of the body and to structures with good
surface to volume ratios that facilitate good exchange (such
as fingers, toes, arms, and legs) will clearly be superior in
patients with good cardiac output. The patient's antemortem
condition will be a major factor in determining how well s/he
will respond to CPR. However, also of great importance is the
use of highly efficient means of CPR and the use of drugs
which prevent shunting of blood away from tissues that need
it, and which prevent shunting of blood through parts of the
lung which are fluid filled or not able to exchabfe oxygen.
No doubt part, but by no means all of the superior cooling
results observed in this patient were as a result of better
perfusion during CPR.

     As can be seen from the table above, patient C-2150, the
subject of this report, cooled at a rate of approximately 1
degree C/min during the first ten minutes post arrest, and at
a rate of 0.56 degrees C/min for the entire 30 minute period
after arrest. This is a rate twice that of a patient with
roughly half his mass and with far less subcutaneous fat
during the first 10 minutes post arrest, and twice that at 30
minutes post arrest. It is also interesting to note that the
30-minute post arrest cooling rates of all three other
patients are well below 0.5 degrees C/min., and are in close
agreement (0.24 and 0.21) for the two patients whose mass,
fat distribution and surface area most closely approximate
those of this patient.

     We believe that this patient experienced such superior
rates of cooling--indeed, rates achieveable in a patient of
his surface area only with extracorporeal (blood/body core)
cooling--because of the following factors:

     * Superior perfusion  due (blood circulation) during CPR
as a result of:
     a) cardiac arrest in the absence of a long period of
agonal shock.
     b)pre-arrest medication which reduced cold
agglutination, prevented loss of
     c) normal vasmotion and adequate control and
distribution of blood flow.
     d) greatly improved cardiac out, mean arterial pressure
(MAP) and decreased venous pressure as a result of ACDC-HICPR
     e) improved oxygenation due to ventilation with each
compression upstroke using ACDC-CPR
     f) inhibition of pulmonary edema as a result of lower
central venous pressures and better mitral valve function as
a result of ACDC-HICPR

     *Superior cooling due to the use of colonic and
peritoneal lavage with ice cold solution in addition to
external cooling using the portable ice bath (PIB) and a
circulating water system to pump ice cold water over the
patient's body.

     The use of these modalaties and the cooling rates
achievable with them was established in dog lab. Further,
other cooling approaches such as the use of ice-slush lavages
in stomach, inaddition to the colon and peritoneum, and the
addition of liquid ventilation (using perfluburon chilled to
0-2 degrees C) or subzero jet gas ventilation, are currently
under investigation (and patent) and may provide for cooling
rates approach 1.5 to 2.0 degrees C per minute if added to
the modalities used in this patient.
     Administration of all transport medications to this
patient was completed at 2340.

     Transport Phase 2: Initiation of Extracorporeal Support
and Total Body Washout

     Surgery to raise the right femoral artery and vein was begun at
23:30 following standard prep of the right groin with Betadine
scrub/solution, and creation of a sterile field with sterile muslin
towels and disposable drapes. Two femoral arteries of 3-5 mm in
diameter were rapidly located and a pressure line was placed in one
at 23:55 (initial pressure measured was MAP 47 mmHg).

     However, despite extensive further dissection of the right groin no
femoral vein could be located. Dissection along the tissue plane
of the femoral arteries failed to reveal the femoral vein (although
the sciatic nerve was identified) and the femoral arteries appeared
to bifurcate within the abdomen. (Subsequent autopsy disclosed that
the patient had no femoral vein and a right iliac artery that
bifurcated into two femoral vessels at the terminus of the
abdominal aorta). Several small veins (3-5 mm in diameter) were
located and one of these opened to determine feasibility of cannula
placement for venous return. While this was deemed not possible,
it was noted that the venous blood was free-flowing and arterial
red in color, indicating adequate oxygen delivery to the patient
(the patient's tympanic temperature at that time was
approximately 23 degrees C, colonic temperature 14.5 degrees
C).

     By 00:15 a decision had been made to abandon the right groin wound
and proceed with surgery to raise the left femoral artery and vein.
Prep of the left groin was made at 00:21 and the femoral artery and
femoral artery and vein were rapidly identified. The femoral vein
was cannulated with a Biomedicus Carmeda-coated, 21 Fr. x 50 cm
venous cannula (#34284).

     However, a further complication occurred in that the femoral artery
was invaded with malignancy; apparently between the tunica media
vasorum and the intima of the vessel. The vessel also was
moderately atherosclerotic (soft yellow atheroma). This
complicated arterial cannulation and required extensive further
dissection of the groin to avoid a dissecting aneurysm of the
entire arterial tree secondary to cannula placement.

     Thumper support was discontinued at 01:07 at a tympanic
temperature of 20.2 degrees C and a colonic temperature of
8.4 degrees C. MAP had dropped to 35 mmHg at this time, and
it was felt that further Thumper support was not productive.

     Both cannulae were in place by 01:18 and closed circuit
femoral-femoral bypass was begun at about 01:18, using a prime
consisting of 750 cc Dextran 40 in Normal saline, 1500 cc of
Normosol-R pH 7.4, 500 cc 20% mannitol in water, and 50 cc (1
mEq/cc) of sodium bicarbonate solution. At 01:21 a "popping sound"
was heard, and the polycarbonate housing of the Sarns 9444 Turbo
oxygenator was noted to have developed a leak at the joint between
the two halves of the housing. This occurred at a pressure of 260
mmHg, well below the 760 mmHg pressure this unit is rated for.

     The problem (popping sound) was noted at exactly 01:20 and the pump
was shut down and lines were clamped at 01:21. The circuit was
carefully inspected for air from the oxygenator through the filter
and up to the patient, and none was noted. The oxygenator was
changed out of the circuit and replaced with a fresh one and the
bypass line was used to prime the new oxygenator and debubble the
circuit. Bypass was resumed uneventfully at 01:33, 12 minutes
later. Closed circuit bypass was continued at a MAP of 45 mmHg and
flow rate of 2-3 liters per minute (LPM).

     When the patient's tympanic temperature reached
approximately 16 degrees C (colonic , 6.2 degrees C) the
patient was progressively hemodiluted with 10 liters of
Viaspan using 2 liters of open circuit flush at a MAP of 45-
50 mmHg. At the conclusion of the Viaspan flushes, the
patient was flushed with 10 liters of 5% (v/v) glycerol in
21CM-BPI-002 base perfusate. Glycerol-containing flush was
introduced slowly in two liter aliquots. Flushing with 5%
glycerol began at 01:42 and was followed by flushing with 10
liters of 10% w/v glycerol perfused in the same fashion.
Flushing with 2 liter aliquots of 10% w/v glycerol was
completed at 02:35. Flushing proceeded more slowly than
normal due to partial cold and chemical-induced rupture of
both plastic bags containing the flush solution, with leakage
which required a great deal of effort to contain.

     At 02:02 the tympanic probe was replaced with a frontal sinus probe
to facilitate movement of the patient at the conclusion of bypass.
It is interesting to note that frontal sinus and tympanic
temperatures agreed to within 0.2 degrees C. Frontal sinus
temperature at the conclusion of flushing/glycerolization was
5.5 degrees C, colonic, 1.6 degrees C.

     Following the conclusion of total body washout and phase I
glycerolization, the patient was disconnected from the
extracorporeal circuit with care taken to avoid introduction
of air into either the arterial or venous cannula (the
cannulae were cross-connected with a short length of 3/8" x
3/32" bypass tubing which was filled with perfusate and
carefully purged of air before the occluding clamps on the
cannulae were removed).

     The patient was then removed from the PIB of the MALSS and placed
in a more easily transportable PIB for transfer to the BPI/21CM
facility for cryoprotective perfusion. Originally it had been
planned that the patient would be moved with extracorporeal
support on the MALSS continuing. However, the patient
occupied a second story apartment with a stairway that became
extremely slick and hazardous during what was the first (and
unexpected) rain of the Los Angeles basin's winter season.
For the safety of the patient and the personnel, a decision
was made not to attempt to transport the 600 pound-plus
MALSS, with the patient in it, down the stairs in heavy rain.

     The patient was transported by BPI ambulance from
Huntington Beach to Rancho Cucamonga, CA starting at
approximately 0350.  Driving conditions were very poor with
heavy rain and an earlier than usual morning rush hour
traffic beginning by the time the freeway was reached at
0400.  The patient arrived at the facility at 0545 on 13
December.

End of PART II