NCT00946400

Validating 4Ts for Heparin Induced Thrombocytopenia (HIT)

Prospectively Validating the 4Ts and Chong Score for Heparin Induced Thrombocytopenia

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 500 (estimated)
• Sponsor: Medstar Health Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Heparin-Induced Thrombocytopenia

Interventions

Type	Name	Description
OTHER	Scoring 4Ts and Chong scale	Two physicians will independently score both the 4Ts and the Chong scale on all patients enrolled in this study.
OTHER	Blood draw	Patient serum will be collected to perform Serotonin Release Assay testing to verify the presence of HIT.

Timeline

• Start date: 2009-08-01
• First posted: 2009-07-27
• Last updated: 2009-07-27

Locations

1 site across 1 country: United States