Validating 4Ts for Heparin Induced Thrombocytopenia (HIT)

Heparin-Induced Thrombocytopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00946400
• Other study ID #: 2009-202
• Status: Not yet recruiting
• Phase: N/A
• First received: July 24, 2009
• Last updated: July 24, 2009
• Start date: August 2009

Study information

• Verified date: July 2009
• Source: Washington Hospital Center
• Contact: Chee M Chan, MD
• Phone: (202) 877-7856
• Email: chee.m.chan[@]medstar.net
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with suspected HIT.

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Heparin-Induced Thrombocytopenia
• Thrombocytopenia
• Thrombocytosis

Intervention

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.
• Blood draw
Patient serum will be collected to perform Serotonin Release Assay testing to verify the presence of HIT.

Locations

Country	Name	City	State
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Washington Hospital Center	GlaxoSmithKline

Country where clinical trial is conducted

United States, 

References & Publications (2)

Chong BH, Chong JJ. Heparin-induced thrombocytopenia. Expert Rev Cardiovasc Ther. 2004 Jul;2(4):547-59. Review. — View Citation

Lo GK, Juhl D, Warkentin TE, Sigouin CS, Eichler P, Greinacher A. Evaluation of pretest clinical score (4 T's) for the diagnosis of heparin-induced thrombocytopenia in two clinical settings. J Thromb Haemost. 2006 Apr;4(4):759-65. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To validate the 4Ts as a pretest probability tool for HIT.		End of study.	No
Primary	To validate the Chong scale as a tool to determine the post-test probability for HIT.		End of study.	No
Secondary	To determine the inter-rater variability for scoring the 4Ts.		End of study.	No
Secondary	To determine the inter-rater variability for scoring the Chong scale.		End of study.	No