Apheresis to Obtain Plasma or White Blood Cells for Laboratory Studies



Status:Recruiting
Healthy:No
Age Range:7 - Any
Updated:4/6/2019
Start Date:December 16, 1992
Contact:Thomas B Nutman, M.D.
Email:tnutman@mail.nih.gov
Phone:(301) 496-5399

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Apheresis Procedures to Obtain Plasma or Leukocytes for In Vitro Studies

This study will collect blood plasma and white blood cells for laboratory research using a
procedure called apheresis. Apheresis is a method of collecting larger quantities of certain
blood components than can safely be collected through a simple blood draw.

Patients 7 years of age and older with a parasitic infection or condition associated with a
parasitic infection (i.e., elevated levels of IgE antibodies or of a type of white cell
called eosinophils) who are currently enrolled in a NIH clinical research protocol may be
eligible for this study. Relatives of patients and normal healthy volunteers will also be
enrolled. Candidates will have a medical history, physical examination and blood tests.
Individuals weighing less than 25 kilograms (55 pounds) may not participate.

Participants will undergo one of the following two apheresis procedures:

- Automated pheresis Whole blood is drawn through a needle placed in an arm vein and
circulated through a cell separator machine. The plasma (liquid part of the blood) and
white cells are extracted, and the red cells are re-infused into the donor through a
needle in the other arm. The procedure takes 1 to 2 hours.

- Manual pheresis Whole blood is drawn through a needle placed in an arm vein and
circulated through the cell separator machine. The red blood cells are separated from
the rest of the blood and returned to the donor through the same needle. Usually only
one needle stick is required and the procedure takes from 30 to 45 minutes. This method
is used only in individuals who weigh less than 35 kg (77 pounds).

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, leukocytes, or platelets
than can be safely obtained by simple phlebotomy. These components can be easily and safely
obtained using apheresis procedures in the Clinical Center Apheresis Unit. This protocol is
specifically designed to conform to the requirements of the Apheresis Unit for donors to have
apheresis procedures (greater than 7 years of age and greater than or equal to 25 kg) but the
protocol in itself is not a research protocol. Donors must first be admitted to another
approved clinical research protocol of the NIAID before they may have the apheresis
procedures described in this protocol.

- INCLUSION CRITERIA:

- Enrolled on another LPD protocol.

- Weight greater than or equal to 25 kg

- Willingness to participate

EXCLUSION CRITERIA:

- Age less than 7 years

- Weight less than 25 kg

- Cardiovascular instability

- Hct less than 30

- Inadequate venous access

- PTT or PT greater than 1.5 normal

- Pregnancy

- Women who are actively breastfeeding

- Other condition which the attending physician or Apheresis Unit staff considers a
contraindication to the procedure

- For Hetastarch procedure

- Hypertension

- Evidence of fluid retention
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Phone: 800-411-1222
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mi
from
Bethesda, MD
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