Recruiting

Observational Study

Sponsor:

University of Arizona

Code:

NCT02717039

Conditions

Heparin-induced Thrombocytopenia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Blood Draw

Study Details

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

Study ID

NCT02717039

Start date

Mar, 2016

Status verified date

Jun, 2024

Completion date

Jul, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

125 participants

Anticipated

Interventions and Outcome Measures

Arms

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).

Interventions

Blood Draw

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.

Primary outcome measure

  • Serotonin Release Assay [ Time Frame: 0-30 days ]
  • Heparin/platelet factor 4 antibody [ Time Frame: 0-30 days ]

Central Contacts and Locations

Central contacts

Jason H Karnes, PharmD, PhD

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

Talin A Robinson-Catalan, MS

520-278-6114talinrobinson@arizona.edu

Locations

Banner University Medical Center - Tucson

Recruiting

Tucson, Arizona, United States, 85721

Contacts

Jason H Karnes, PharmD, PhD

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

More Information

Sponsor

University of Arizona

Last update posted

Jun 27, 2024

Last verified

Jun, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arizona on 2024-06-27.