Validating 4Ts for Heparin Induced Thrombocytopenia (HIT)

• Conditions: Heparin-Induced Thrombocytopenia

• Registration Number: NCT00946400
• Lead Sponsor: Medstar Health Research Institute

Brief Summary

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.

Detailed 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.

Study Timeline

• Status Verified: 2009-07
• Study First Submitted: 2009-07-24
• Study First Submitted QC: 2009-07-24
• Last Update Submitted: 2009-07-24
• Study First Posted: 2009-07-27
• Last Update Posted: 2009-07-27
• Study Start: 2009-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Patients with suspected HIT.

Exclusion Criteria

• None.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To validate the Chong scale as a tool to determine the post-test probability for HIT.	End of study.
To validate the 4Ts as a pretest probability tool for HIT.	End of study.

Secondary Outcome Measures

Name	Time	Method
To determine the inter-rater variability for scoring the 4Ts.	End of study.
To determine the inter-rater variability for scoring the Chong scale.	End of study.

Trial Locations

Locations (1)

Washington Hospital Center; 🇺🇸 Washington, District of Columbia, United States