Blood Donation--Immune Sequelae and Recruitment

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005341
First received: May 25, 2000
Last updated: June 23, 2005
Last verified: May 2000
  Purpose

To determine if there were immune sequelae related to the long-term donation of blood or blood products.


Condition
Blood Disease
Blood Donors

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: February 1992
Estimated Study Completion Date: January 1997
Detailed Description:

DESIGN NARRATIVE:

The study had two objectives. The first objective was to investigate changes in immune function which may have occurred as a result of blood, plasma, or platelet donations. Preliminary studies had shown evidence of alterations in immune parameters in normal apheresis donors with the most marked changes occurring in long-term plasmapheresis donors. To ascertain whether donation of blood or blood products altered specific immune parameters, studies were conducted on white blood cell (WBC) receptors known to be involved in normal host defense mechanisms, lymphocyte subpopulations, plasma proteins, and complement activation products from 30 individuals in each of four separate donor groups: whole blood donors, bulk plasma donors, plasma donors stimulated with incompatible RBC, and platelet donors. Donor immune data were compared with results in nondonor controls and were also correlated with demographic data, donation history, laboratory data, and clinical findings. The second objective of the study was to determine if changes in an individual donor's immune status occurred over time. A longitudinal study of 15 new donors in each donation group was performed to evaluate alterations in immune function that may have occurred in committed donors of blood products and whether there was any clinical significance to the findings. New donors were enrolled in donation groups and followed longitudinally for a period of up to two years.

The study was extended through January, 1997 on FY 1995 funds.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
No Contacts or Locations Provided
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00005341     History of Changes
Other Study ID Numbers: 4204
Study First Received: May 25, 2000
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Hematologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014