Effects of Antibodies to White Blood Cells on Platelet Transfusion Patients

Sponsor
National Institutes of Health Clinical Center (CC) (NIH)
Overall Status
Completed
CT.gov ID
NCT00460122
Collaborator
(none)
135
1
64
2.1

Study Details

Study Description

Brief Summary

This study will determine if transfusion of platelets containing HLA antibodies (certain antibodies to white blood cells) are more likely to cause transfusion reactions than transfusion of platelets that do not contain HLA antibodies.

People 18 years of age or older who donate platelets at the NIH Clinical Center may be eligible for this study.

An extra tube of blood (about one teaspoon) is obtained from participating donors at the time of their donation at the NIH Platelet Center. The blood plasma in the extra tube is tested for HLA antibodies and antibodies to certain white blood cells called granulocytes. The research sample is assigned a code number for identification and sent to the HLA Laboratory in the Department of Transfusion Medicine.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Leukocyte antibodies can cause febrile transfusion reactions, pulmonary reactions to granulocyte transfusions, and transfusion related acute lung injury (TRALI). Despite the fact that the role of leukocyte antibodies in these reactions was first described almost 50 years ago, and that TRALI is now the leading cause of transfusion related fatalities, much remains uncertain concerning the role of HLA antibodies in these reactions. The primary purpose of this study is to retrospectively and prospectively determine if the incidence and nature of transfusion reactions differs in Clinical Center (CC) patients that were transfused with platelet components from donors with HLA antibodies and those without HLA antibodies. In addition, this study will prospectively determine the incidence of HLA antibodies in the NIH Department of Transfusion Medicine (DTM) platelet donor population. In this natural history study a 10-mL blood sample will be drawn from 600 platelet donors at the time that they are in the DTM donating platelets and it will be tested for HLA antibodies in the DTM. The blood sample for HLA antibody testing will be collected with other samples collected as part of the regular platelet donation process. Reactions in platelet transfusion recipients will be assessed by reviewing CC and DTM patient records.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    135 participants
    Time Perspective:
    Other
    Official Title:
    Pilot Study of the Incidence of HLA Class I and Class II Antibodies in Platelet Donors and Their Effects on the Transfusion Recipient
    Study Start Date :
    Apr 10, 2007
    Study Completion Date :
    Aug 10, 2012

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      • INCLUSION CRITERIA:
      1. Both male and female donors

      2. Any ethnic group

      3. 18 years of age or older

      4. Must meet the criteria for donating platelets in the DTM

      EXCLUSION CRITERIA:
      1. Donors are not eligible to donate platelets in the DTM

      Contacts and Locations

      Locations

      Site City State Country Postal Code
      1 National Institutes of Health Clinical Center, 9000 Rockville Pike Bethesda Maryland United States 20892

      Sponsors and Collaborators

      • National Institutes of Health Clinical Center (CC)

      Investigators

      • Principal Investigator: David F Stroncek, M.D., National Institutes of Health Clinical Center (CC)

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      Responsible Party:
      , ,
      ClinicalTrials.gov Identifier:
      NCT00460122
      Other Study ID Numbers:
      • 070125
      • 07-CC-0125
      First Posted:
      Apr 13, 2007
      Last Update Posted:
      Dec 12, 2019
      Last Verified:
      Aug 10, 2012
      Keywords provided by , ,
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Dec 12, 2019