In order to undergo apheresis procedures, patients will be admitted to active clinical research protocols approved by the ICRS. Relatives and normal volunteers may undergo apheresis without first being on an active clinical protocol. Women who are pregnant and normal children will not be studied.
In order to undergo apheresis procedures, as a minimum, patients, family members and control subjects must have a recent history and physical examination, as well as CBC and differential count. Appropriate chemistry and coagulation studies will be performed when clinically indicated. If indicated, a pregnancy test may be performed.
Patients and volunteers undergoing apheresis will be tested against HIV, HBsAg and HCV, if not tested in the previous year.
To be eligible for apheresis for research purposes, children must be at least 7 years old, weigh 25 kilograms, have adequate peripheral access to insert needles for apheresis, and be able to undergo apheresis without sedation. If children between the ages of seven and twelve years are to undergo apheresis, a third party not otherwise involved with the protocol ; e.g., Bioethicist, Patient Advocate, must talk with the child independently to ensure that the child understands the procedure and freely agrees to participate. This protocol alone is not intended for general study of patients, but only as an adjunct protocol to allow for apheresis procedures.
For patients, the following minimal criteria are required to undergo the procedure:
- Adequate peripheral venous access;
- No need for sedation;
- Weight greater than 25 kg;
- Hematocrit greater than 27%;
- Platelet count greater than 75,000/microL;
- For patients, the hematological values have to be current (up to a week before the procedure).
Healthy volunteers and relatives will have a CBC performed up to 4 weeks before the procedure. In order to be able to undergo the procedure, they must fulfill all of the below:
- Hemoglobin greater than 11 g/dL for males and greater than 10 g/dL for females;
- Platelet count greater than 150,000 microL;
- WBC greater than 3.5 x 10(3) /microL;
- MCV above 80;
- Negative HIV, HCV and HBsAg serologies in the past year.
Patients will not undergo apheresis procedures if they have cardiovascular instability, severe anemia, inadequate venous access, severe coagulation disorder, are pregnant, or have any other condition which the attending physician or Apheresis Clinic staff considers a contraindication to the procedure.
For children, exclusion criteria include age less than 7 years, weigh less than 25 kilograms, inadequate peripheral access to insert needles for apheresis, and unable to undergo apheresis without sedation.