Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 2 for:    pharmacogenomics of heparin
Previous Study | Return to List | Next Study

Pharmacogenomics of Heparin-Induced Thrombocytopenia (PHIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02717039
Recruitment Status : Recruiting
First Posted : March 23, 2016
Last Update Posted : January 25, 2019
Sponsor:
Collaborator:
American College of Clinical Pharmacy
Information provided by (Responsible Party):
Jason H Karnes, University of Arizona

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.

Condition or disease Intervention/treatment
Heparin-induced Thrombocytopenia Procedure: Blood Draw

  Show Detailed Description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 125 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Pharmacogenomics of Heparin-Induced Thrombocytopenia
Actual Study Start Date : March 2016
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Group/Cohort Intervention/treatment
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
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 Measures :
  1. Serotonin Release Assay [ Time Frame: 0-30 days ]
    Functional assay confirming presence of heparin-induced thrombocytopenia

  2. Heparin/platelet factor 4 antibody [ Time Frame: 0-30 days ]
    ELISA for confirming presence of heparin/PF4 antibodies necessary for HIT


Biospecimen Retention:   Samples With DNA
Whole blood will be stored in freezers at minus 80 degrees


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02717039


Contacts
Layout table for location contacts
Contact: Jason H Karnes, PharmD, PhD 520-626-1447 karnes@pharmacy.arizona.edu
Contact: Heidi M Steiner, BS 520-626-3326 steiner@pharmacy.arizona.edu

Locations
Layout table for location information
United States, Arizona
Banner University Medical Center - Tucson Recruiting
Tucson, Arizona, United States, 85721
Contact: Jason H Karnes, PharmD, PhD    520-626-1447    karnes@pharmacy.arizona.edu   
Sponsors and Collaborators
University of Arizona
American College of Clinical Pharmacy

Layout table for additonal information
Responsible Party: Jason H Karnes, Assistant Professor, University of Arizona
ClinicalTrials.gov Identifier: NCT02717039     History of Changes
Other Study ID Numbers: 1512277980
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases
Heparin
Calcium heparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action