Pharmacogenomics of Heparin-Induced Thrombocytopenia

NCT02717039 | Recruiting

• 1 other identifier: 1512277980
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Heparin-induced Thrombocytopenia

Outcome Measures

Primary Outcomes (2)

• Serotonin Release Assay

  Functional assay confirming presence of heparin-induced thrombocytopenia

  0-30 days

• Heparin/platelet factor 4 antibody

  ELISA for confirming presence of heparin/PF4 antibodies necessary for HIT

  0-30 days

Study Arms (1)

Blood Draw

A one time blood draw of 50mL or 15mL 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. Participants will be enrolled in equal numbers from three categories determined by their observed clinical course: (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).

Procedure: Blood Draw

Interventions

Blood Draw PROCEDURE

A 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.

Blood Draw

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from a hospital setting and identified based on laboratory testing for heparin-induced thrombocytopenia.

You may qualify if:

• 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

You may not qualify if:

• 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
• Inability to give informed consent

Sponsors & Collaborators

• University of Arizona: lead
• American College of Clinical Pharmacy: collaborator

Study Sites (1)

Banner University Medical Center - Tucson

Tucson, Arizona, 85721, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood will be stored in freezers at minus 80 degrees

MeSH Terms

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Jason H Karnes, PharmD, PhD

CONTACT

520-626-1447; karnes@pharmacy.arizona.edu

Talin A Robinson-Catalan, MS

CONTACT

520-278-6114; talinrobinson@arizona.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: March 23, 2016
• Study Start: March 1, 2016
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: June 27, 2024

Record last verified: 2024-06

Locations

US (1)