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Apheresis to Obtain Plasma or White Blood Cells for Laboratory Studies



Apheresis to Obtain Plasma or White Blood Cells for Laboratory Studies

For Condition: Leukopheresis,Plasmapheresis
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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).
Details: 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 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.
Eligibility:
Study Type:
  Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Children over the age of 7 years who weigh at least 25 kg and would not require sedation for apheresis will be included. EXCLUSION CRITERIA: Patients will not undergo apheresis procedures if they have cardiovascular instability, severe anemia (Hct less than 30), inadequate venous access, severe coagulation disorders (PTT or PT greater than 1.5 normal), are pregnant, or have any other condition which the attending physician or Apheresis Unit staff considers a contraindication to the procedure. The Hetastarch procedure will not be used in patients with hypertension or evidence of fluid retention.
Total Enrollment: 300

Location and Contact Information:

National Institute of Allergy and Infectious Diseases (NIAID) *Recruiting*
Bethesda,  Maryland,  20892
United States
Recruiting Patient  and Public Liaison Office 1-800-411-1222


Additional Information:
Study ID Numbers:
  930057;  93-I-0057
Study Start Date: December 15, 1992
Record last reviewed: November 19, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001349

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