Blood Donation--Immune Sequelae and Recruitment

Blood Disease Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00005341
• Other study ID #: 4204
• Secondary ID: R01HL045642
• Status: Terminated
• Start date: February 1992
• Est. completion date: January 1997

Study information

• Verified date: March 2024
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Est. completion date: January 1997
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 0 Years to 100 Years
• Eligibility: No eligibility criteria

Related Conditions & MeSH terms

• Blood Disease
• Blood Donors
• Hematologic Diseases

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of New Mexico	National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (1)

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. — View Citation