NCT00562601

LCI Apheresis to Obtain Plasma or White Blood Cells

Apheresis Procedures to Obtain Plasma or Leukocytes for In Vitro Studies

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 864 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 2 Years
• Healthy volunteers: Accepted

Summary

This study will collect blood plasma and white blood cells from individuals 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 or blood donation process. The blood components will be used in laboratory research studies to investigate aspects of infectious and immunologic allergic diseases. Patients 7 years of age and older who are currently enrolled in a NIH clinical research protocol may participate in this study. (Children between the ages of 2 and 6 may participate if they will benefit clinically from undergoing apheresis.) Family members of patients and normal healthy volunteers will also be enrolled. * For all adults and children weighing 55 pounds or more. Blood is drawn through a needle placed in an arm vein and circulated through a cell separator machine. The plasma and white cells are extracted, and the red cells are returned to the donor through a needle in the other arm. The procedure takes from 1 to 2 hours. * For children weighing less than 55 pounds. One unit (1 pint) of blood is drawn through a needle placed in an arm vein, similar to donating a pint of whole blood. The red blood cells are separated from the rest of the blood and returned to the donor through the same needle. This procedure requires only one needlestick and takes about 30 to 45 minutes to complete. In some circumstances, the procedure must be repeated one or more times in order to obtain large enough quantities of plasma or cells for study.

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 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.

Conditions

• Apheresis

Timeline

• Start date: 1988-03-28
• Primary completion: 2020-01-14
• Completion: 2020-01-14
• First posted: 2007-11-22
• Last updated: 2020-01-18

Locations

1 site across 1 country: United States