Validating 4Ts for Heparin Induced Thrombocytopenia (HIT)
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|ClinicalTrials.gov Identifier: NCT00946400|
Recruitment Status : Unknown
Verified July 2009 by Medstar Health Research Institute.
Recruitment status was: Not yet recruiting
First Posted : July 27, 2009
Last Update Posted : July 27, 2009
|Condition or disease||Intervention/treatment|
|Heparin-Induced Thrombocytopenia||Other: Scoring 4Ts and Chong scale Other: Blood draw|
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 Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Prospectively Validating the 4Ts and Chong Score for Heparin Induced Thrombocytopenia|
|Study Start Date :||August 2009|
Those who are clinically suspected of having HIT will be enrolled in this study.
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.
- To validate the 4Ts as a pretest probability tool for HIT. [ Time Frame: End of study. ]
- To validate the Chong scale as a tool to determine the post-test probability for HIT. [ Time Frame: End of study. ]
- To determine the inter-rater variability for scoring the 4Ts. [ Time Frame: End of study. ]
- To determine the inter-rater variability for scoring the Chong scale. [ Time Frame: End of study. ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00946400
|Contact: Chee M Chan, MD||(202) email@example.com|
|United States, District of Columbia|
|Washington Hospital Center|
|Washington, District of Columbia, United States, 20010|
|Sub-Investigator: Andrew F Shorr, MD, MPH|
|Sub-Investigator: Christian Woods, MD|
|Principal Investigator:||Chee M Chan, MD||Medstar Health Research Institute|
|Study Director:||Andrew F Shorr, MD, MPH||Medstar Health Research Institute|