Heparin-induced Thrombocytopenia Clinical Trial
NCT number | NCT02526485 |
Other study ID # | 150433 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 2015 |
Est. completion date | September 5, 2018 |
Verified date | February 2020 |
Source | Vanderbilt University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | September 5, 2018 |
Est. primary completion date | September 5, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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), and 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 |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University Medical Center | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University Medical Center | American Heart Association |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serotonin Release Assay | Functional assay confirming presence of heparin-induced thrombocytopenia | 0-30 days | |
Primary | Heparin/platelet factor 4 antibody | ELISA for confirming presence of heparin/PF4 antibodies necessary for HIT | 0-30 days |
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