LCI Apheresis to Obtain Plasma or White Blood Cells

In order to carry out in vitro research procedures on the plasma or leukocyte components of
blood, it is often necessary to obtain larger quantities of plasma or leukocytes than can be
safely obtained by simple phlebotomy. These components can be easily and safely obtained
using apheresis procedures performed in the Apheresis Clinic of the Department of Transfusion
Medicine, Clinical Center. This protocol is specifically designed to conform to the
requirements of the Apheresis Clinic for donors to have apheresis procedures, but the
protocol in itself is not a research protocol. Patients must first be admitted to another
approved clinical research protocol of the NIAID before they may have the apheresis
procedures described in this protocol. Family members and healthy volunteers may undergo
apheresis using only this protocol, without the necessity for entry into any other protocol.

- INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

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.