Blood Donation--Immune Sequelae and Recruitment
Primary Purpose
Blood Disease, Blood Donors
Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Blood Disease
Eligibility Criteria
No eligibility criteria
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00005341
First Posted
May 25, 2000
Last Updated
January 14, 2016
Sponsor
University of New Mexico
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00005341
Brief Title
Blood Donation--Immune Sequelae and Recruitment
Study Type
Observational
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
February 1992 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 1997 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of New Mexico
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
To determine if there were immune sequelae related to the long-term donation of blood or blood products.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Disease, Blood Donors
7. Study Design
10. Eligibility
Sex
Male
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
No eligibility criteria
12. IPD Sharing Statement
Citations:
PubMed Identifier
8981728
Citation
Kutvirt SG, Armon ME, Simon TL, Lewis SL. Lymphocyte phenotypes and infection incidence in transfused preterm neonates. Transfus Med. 1996 Dec;6(4):329-36. doi: 10.1111/j.1365-3148.1996.tb00092.x.
Results Reference
background
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Blood Donation--Immune Sequelae and Recruitment
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