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Blood Donation--Immune Sequelae and Recruitment

Primary Purpose

Blood Disease, Blood Donors

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
University of New Mexico
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Blood Disease

Eligibility Criteria

undefined - 100 Years (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

No eligibility criteria

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    May 25, 2000
    Last Updated
    January 14, 2016
    Sponsor
    University of New Mexico
    Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)
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    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
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    Blood Donation--Immune Sequelae and Recruitment

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