OBJECTIVE:   To obtain a pancreas from a suitable donor who meets certain criteria.
PROCEDURE:
To review key aspects to determine human pancreas donor:
1.  Islet Specific Inclusion Criteria
a)  Multi-organ donor
b)  Adequate in situ hypothermic perfusion
c)  University of Wisconsin (UW) solution for perfusion and cold storage
d)  Maximum 12 hour cold ischemia
e)  Minimum 25 years to 70 years
f)  Death caused by: Craniocerebral trauma
Spontaneous Intracranial bleeding
Brain Infarction
Primary Brain Tumor
Acute Occlusive Hydrocephalus
  g)  Hospitalization stay < 96 hours
2.  Islet Specific Exclusion Criteria
a)  Warm ischemia exceeding 10 minutes
b)  Pre-existing diseases:  Diabetes mellitus type 1 or 2
Malignancies other than primary brain tumor
Septicemia
c)  Circulation / Blood Pressure: Prolonged hypotensive episodes are exclusion criteria only when they have caused significant biochemical abnormalities (e.g. elevation of serum creatinine levels by more than 50% of the initial value or elevation of transaminases to levels greater than two times the normal values).
d)  Cardiac arrest is an exclusion criterion only when constantly stable circulation could not be achieved throughout the following two days or if significant biochemical abnormalities (see above) occurred.
e)  Vasopressors: Norepinephrine—if required for maintenance of stable circulation.
f)  Dopamine, levophed, and dobutamine are not exclusion criteria.
g)  Elevated amylase or lipase may not constitute exclusion.
3.  General Donor Preclusions / Exclusions
The following are frequently encountered disease states or other conditions, which will be absolute grounds for rejection of a potential donor:
a)  Clinical or active viral Hepatitis (A, B, or C)
b)  Acquired Immunodeficiency Syndrome (AIDS)
c)  HIV seropositivity (HIVI or HIVII)
d)  HTLVIII
e)  Syphilis
f)  Active viral encephalitis or encephalitis of unknown origin
g)  Creutzfeldt–Jacob Disease
h)  Rabies
i)  Treated or Active Tuberculosis
j)  Septicemia
k)  Dementia
l)  Individuals who have received pithGH (pituitary growth hormone)
m)  Malignancies except primary brain tumors
n)  Serious illness of unknown etiology
4.  Behavior – History Exclusionary Criteria
a)  Men who have had sex with another man in the past five years
b)  Persons who report non medical intravenous, intramuscular, or subcutaneous injection of drugs in the past five years
c)  Persons with hemophilia or related clotting disorders who have received human derived clotting factor concentrates
d)  Men and women who have engaged in prostitution in the last five years
e)  Sexual partners engaging in any of the above
f)  Persons who have been exposed in the preceding 12 months to known or suspected HIV infected blood through accidental needle stick or through contact with an open wound, non-intact skin, or mucous membrane
g)  Persons with a history of tattooing, ear and or body piercing, or acupuncture within 12 months preceding tissue donation
h)  Inmates of correctional systems. (This exclusion is to address issues such as difficulties with informed consent and increased prevalence of HIV in this population)
5.  Laboratory and Other Medical Exclusionary Criteria
a)  Persons who cannot be tested for HIV infection because of refusal, inadequate blood samples (e.g. hemodilution that could result in false-negative tests), or any other reasons
b)  Persons with a repeatedly reactive screening assay for HIVI or HIVII antibody regardless of the results of supplemental assays.
c)  Persons whose history, physical examination, medical records, or autopsy reports reveal other evidence of HIV infection or high-risk behavior, such as a diagnosis of AIDS, unexplained weight loss, night sweats, blue or purple spots on the skin or mucous membranes typical of Kaposi’s sarcoma, unexplained lymphadenopathy lasting > 1 month, unexplained temperature > 100.5° F (38.6° C) for > 10 days, unexplained persistent cough and shortness of breath, opportunistic infections, unexplained persistent diarrhea, male-to-male sexual contact, sexually transmitted diseases, or needle tracks or other signs of parenteral drug abuse.

2003-10-10 22:45

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