Pharmacogenomics of Heparin-Induced Thrombocytopenia
ConditionHeparin-induced Thrombocytopenia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Arizona
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years of age or older
Ability to give informed consent
Have undergone testing for heparin/PF4 antibody with or without SRA testing for HIT
Have received treatment with unfractionated heparin or low molecular weight heparin (enoxaparin, dalteparin, tinzaparin) prior to antibody or SRA testing
Disqualifiers
Less than 18 years of age
Pregnancy
Hemoglobin less than 9 mg/dL (for larger 5 ounce blood draw)
Known Human Immunodeficiency Virus (HIV) infection
Trial population
Patients will be recruited from a hospital setting and identified based on laboratory testing for heparin-induced thrombocytopenia.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Blood Draw
Procedure/SurgeryA one time blood draw of 150 milliliters will be performed using a vein in the participants arm. Existing venous access will be used for the blood draw in preference of new venipuncture.
Treatment groups
125 Participants
are divided into 1 treatment groupGroup A: Blood Draw1 intervention
Trial outcomes
Primary outcomes
1
Serotonin Release Assay
Functional assay confirming presence of heparin-induced thrombocytopenia
Time frame
0-30 days2
Heparin/platelet factor 4 antibody
ELISA for confirming presence of heparin/PF4 antibodies necessary for HIT
Time frame
0-30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Arizona
Lead sponsor
American College of Clinical Pharmacy
Collaborator
Source ClinicalTrials.gov