Effects of Antibodies to White Blood Cells on Platelet Transfusion Patients

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00460122
• Other study ID #: 070125
• Secondary ID: 07-CC-0125
• Status: Completed
• Start date: April 10, 2007
• Est. completion date: August 10, 2012

Study information

• Verified date: August 10, 2012
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: August 10, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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

Related Conditions & MeSH terms

• Healthy
• Transfusion Reaction
• Transfusion Reactions

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institutes of Health Clinical Center (CC)

Country where clinical trial is conducted

United States, 

References & Publications (3)

BRITTINGHAM TE. Immunologic studies on leukocytes. Vox Sang. 1957 Sep;2(4):242-8. — View Citation

Goldman M, Webert KE, Arnold DM, Freedman J, Hannon J, Blajchman MA; TRALI Consensus Panel. Proceedings of a consensus conference: towards an understanding of TRALI. Transfus Med Rev. 2005 Jan;19(1):2-31. — View Citation

Toy P, Popovsky MA, Abraham E, Ambruso DR, Holness LG, Kopko PM, McFarland JG, Nathens AB, Silliman CC, Stroncek D; National Heart, Lung and Blood Institute Working Group on TRALI. Transfusion-related acute lung injury: definition and review. Crit Care Med. 2005 Apr;33(4):721-6. Review. — View Citation