NCT00460122

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2007

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 13, 2007

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2012

Completed
Last Updated

December 12, 2019

Status Verified

August 10, 2012

First QC Date

April 12, 2007

Last Update Submit

December 11, 2019

Conditions

HealthyTransfusion Reactions

Keywords

Human Leukocyte Antigens (HLA)Transfusion ReactionsPlatelet Donors

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both male and female donors
  • Any ethnic group
  • years of age or older
  • Must meet the criteria for donating platelets in the DTM

You may not qualify if:

  • \. Donors are not eligible to donate platelets in the DTM

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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. doi: 10.1097/01.ccm.0000159849.94750.51.

    PMID: 15818095BACKGROUND

  • 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. doi: 10.1016/j.tmrv.2004.10.001.

    PMID: 15830325BACKGROUND

  • BRITTINGHAM TE. Immunologic studies on leukocytes. Vox Sang. 1957 Sep;2(4):242-8. doi: 10.1111/j.1423-0410.1957.tb03699.x. No abstract available.

    PMID: 13496693BACKGROUND

MeSH Terms

Conditions

Transfusion Reaction

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesImmune System Diseases

Study Officials

  • David F Stroncek, M.D.

    National Institutes of Health Clinical Center (CC)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
OTHER
Sponsor Type
NIH

Study Record Dates

First Submitted

April 12, 2007

First Posted

April 13, 2007

Study Start

April 10, 2007

Study Completion

August 10, 2012

Last Updated

December 12, 2019

Record last verified: 2012-08-10

Locations

US(1)