Validating 4Ts for Heparin Induced Thrombocytopenia (HIT)

NCT ID: NCT00946400

Last Updated: 2009-07-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-08-31

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.

Conditions

Heparin-Induced Thrombocytopenia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Suspected HIT

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

Scoring 4Ts and Chong scale

Intervention Type: OTHER

Two physicians will independently score both the 4Ts and the Chong scale on all patients enrolled in this study.

Blood draw

Intervention Type: OTHER

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

Interventions

Scoring 4Ts and Chong scale

Two physicians will independently score both the 4Ts and the Chong scale on all patients enrolled in this study.

Intervention Type: OTHER

Blood draw

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with suspected HIT.

Exclusion Criteria

• None.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: collaborator

Medstar Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Medstar Research Institute

Principal Investigators

Chee M Chan, MD

Role: PRINCIPAL_INVESTIGATOR

Medstar Health Research Institute

Andrew F Shorr, MD, MPH

Role: STUDY_DIRECTOR

Medstar Health Research Institute

Locations

Washington Hospital Center

Washington D.C., District of Columbia, United States

Countries

United States

Central Contacts

Chee M Chan, MD

Role: CONTACT

chee.m.chan@medstar.net

(202) 877-7856

References

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. doi: 10.1111/j.1538-7836.2006.01787.x.

Reference Type: BACKGROUND

PMID: 16634744 (View on PubMed)

Chong BH, Chong JJ. Heparin-induced thrombocytopenia. Expert Rev Cardiovasc Ther. 2004 Jul;2(4):547-59. doi: 10.1586/14779072.2.4.547.

Reference Type: BACKGROUND

PMID: 15225114 (View on PubMed)

Chan CM, Woods CJ, Warkentin TE, Sheppard JI, Shorr AF. The Role for Optical Density in Heparin-Induced Thrombocytopenia: A Cohort Study. Chest. 2015 Jul;148(1):55-61. doi: 10.1378/chest.14-1417.

Reference Type: DERIVED

PMID: 25611568 (View on PubMed)

Other Identifiers

2009-202

Identifier Type: -

Identifier Source: org_study_id