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Apheresis to Obtain Plasma or White Blood Cells for Laboratory Studies
This study is currently recruiting participants.
Verified by National Institutes of Health Clinical Center (CC), October 2008
Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00001349
  Purpose

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).

Condition
Leukopheresis
Plasmapheresis

U.S. FDA Resources
Study Type: Observational
Official Title: Apheresis Procedures to Obtain Plasma or Leukocytes for In Vitro Studies

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 300
Study Start Date: December 1992
Detailed Description:

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

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:
  • Enrolled on another LPD protocol.
  • Weight greater than 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
  • Other condition which the attending physician or Apheresis Unit staff considers a contraindication to the procedure
  • For Hetastarch procedure
  • Hypertension
  • Evidence of fluid retention
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001349

Contacts
Contact: Patient Recruitment and Public Liaison Office (800) 411-1222 prpl@mail.cc.nih.gov
Contact: TTY 1-866-411-1010

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site

Publications:
Study ID Numbers: 930057, 93-I-0057
Study First Received: November 3, 1999
Last Updated: November 14, 2008
ClinicalTrials.gov Identifier: NCT00001349  
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Plasmapheresis
Lymphocytes
Eosinophils
Neutrophils

ClinicalTrials.gov processed this record on January 15, 2009