Clinical Trial: Pharmacogenomics of Heparin-Induced Thrombocytopenia

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Pharmacogenomics of Heparin-Induced Thrombocytopenia

Brief Summary: The purpose of this research is to identify genomic markers that can predict heparin-induced thrombocytopenia (HIT), which is a very serious side effect to heparin. Heparin is commonly used to prevent blood clots and the investigators may be able to identify genomic markers which can be used to prevent heparin use in people who will get HIT.

Detailed Summary:

Inclusion Criteria: 18 years of age or older; Ability to give informed consent; Participants with heparin/PF4 antibody and SRA testing for HIT, including:

participants with negative heparin/PF4 antibodies and negative SRA (controls), participants with positive heparin/PF4 antibodies and negative SRA(seroconversion cases), participants with positive heparin/PF4 antibodies and positive SRA (HIT cases); Treatment with unfractionated heparin or low molecular weight heparin (enoxaparin, dalteparin, tinzaparin) within 7 days of blood draw Exclusion Criteria: Less than 18 years of age; Inability to give informed consent There is no randomization involved in this study. Participants will be enrolled in equal numbers from three categories: (1) participants without HIT testing negative for heparin/PF4 antibodies (controls); (2) participants without HIT testing positive for heparin/PF4 antibodies (seroconversion cases); (3) participants with HIT testing positive for both heparin/PF4 antibodies (HIT cases).

Recruitment will be facilitated through collaborators in the Coagulation Laboratory and through key study personnel in the Banner Univerisyt Medical Center - Tucson. Patients with positive and negative heparin/PF4 antibody and serotonin release assay results will be identified in the Coagulation Laboratory and the patient's provider will be approached about potential participation in research studies. If the potential participant is interested, they will be approached by study personnel for study description and possible consent. Alternatively, clinical collaborators who are consulted and participating directly in a patients care may contact a potential participant directly for willingness to participate in the study.

Patients consenting to the study will be asked to provide a one b
Sponsor: University of Arizona

Current Primary Outcome:

• Serotonin Release Assay [ Time Frame: 0-30 days ]
  Functional assay confirming presence of heparin-induced thrombocytopenia
• Heparin/platelet factor 4 antibody [ Time Frame: 0-30 days ]
  ELISA for confirming presence of heparin/PF4 antibodies necessary for HIT

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Arizona

Dates:
Date Received: March 17, 2016
Date Started: March 2016
Date Completion: December 2018
Last Updated: October 27, 2016
Last Verified: October 2016