Validating 4Ts for Heparin Induced Thrombocytopenia (HIT)

MedStar Health

Status: Unknown

Conditions: Heparin-Induced Thrombocytopenia

Treatments: Other: Blood draw; Other: Scoring 4Ts and Chong scale

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00946400

2009-202

Details and patient eligibility

About

The purpose of this study is to evaluate a scoring tool to help determine the presence of Heparin Induced Thrombocytopenia (HIT), which is an adverse reaction to heparin. We hypothesize that this scoring tool will be very useful in excluding patients who are suspected of having HIT.

Full description

HIT is an immune response to heparin that can result in thrombogenic thrombocytopenia. It is often a difficult diagnosis to make, and its diagnosis is dependent upon both clinical and serologic criteria. Due to this ambiguity, increased testing and treatment may occur until serologic test results return. Recently, scoring tools have been developed to assist with the diagnosis of this disease. However, these scoring tools have yet to be validated. Thus, we plan to conduct a prospective, observational study to validate two scoring tools, the 4Ts and the Chong scale, in the diagnosis of HIT.

In order to validate these scoring tools, two physicians will independently score the 4Ts and the Chong scale for all patients suspected of having HIT. These patients will be identified if a physician has ordered HIT antibody testing using the enzyme immunoassay (EIA) method. Confirmatory testing with a serotonin release assay (SRA) will also be performed.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with suspected HIT.

Exclusion criteria

• None.

Trial design

500 participants in 1 patient group

Suspected HIT

Description:

Those who are clinically suspected of having HIT will be enrolled in this study.

Treatment:

Other: Scoring 4Ts and Chong scale

Other: Blood draw