Effects of Antibodies to White Blood Cells on Platelet Transfusion Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00460122
Recruitment Status : Completed
First Posted : April 13, 2007
Last Update Posted : July 17, 2018
Information provided by:
National Institutes of Health Clinical Center (CC)

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
Healthy Transfusion Reactions

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 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 : April 10, 2007
Study Completion Date : August 10, 2012

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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

    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


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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00460122

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institutes of Health Clinical Center (CC)
Principal Investigator: David F Stroncek, M.D. National Institutes of Health Clinical Center (CC)

Publications: Identifier: NCT00460122     History of Changes
Other Study ID Numbers: 070125
First Posted: April 13, 2007    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: August 10, 2012

Keywords provided by National Institutes of Health Clinical Center (CC):
Human Leukocyte Antigens (HLA)
Transfusion Reactions
Platelet Donors

Additional relevant MeSH terms:
Transfusion Reaction
Hematologic Diseases
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs