Immunogenetics of Heparin-Induced Thrombocytopenia: Aim 2

NCT02526485 | Completed

• 1 other identifier: 150433
• Study Type: observational
• Target: 15
• 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

Keywords

heparin; thrombocytopenia; genomics

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 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. 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
• 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

You may not qualify if:

• Less than 18 years of age
• Inability to give informed consent

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• American Heart Association: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood will be stored in freezers at minus 80 degrees.

MeSH Terms

Conditions

Thrombocytopenia

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Intervention Hierarchy (Ancestors)

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

Study Officials

• Elizabeth Phillips Phillips, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 3, 2015
• First Posted: August 18, 2015
• Study Start: March 1, 2015
• Primary Completion: September 5, 2018
• Study Completion: September 5, 2018
• Last Updated: February 17, 2020

Record last verified: 2020-02

Locations

US (1)