Effects of Antibodies to White Blood Cells on Platelet Transfusion Patients

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00460122
First received: April 12, 2007
Last updated: January 14, 2014
Last verified: August 2012
  Purpose

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
Healthy
Transfusion Reactions

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment: 135
Study Start Date: April 2007
Estimated Study Completion Date: August 2012
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00460122

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

Publications:
ClinicalTrials.gov Identifier: NCT00460122     History of Changes
Other Study ID Numbers: 070125, 07-CC-0125
Study First Received: April 12, 2007
Last Updated: January 14, 2014
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Blood Group Incompatibility
Hematologic Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014