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| Name | Class |
|---|---|
| GlaxoSmithKline | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suspected HIT | Those who are clinically suspected of having HIT will be enrolled in this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scoring 4Ts and Chong scale | Other | Two physicians will independently score both the 4Ts and the Chong scale on all patients enrolled in this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To validate the 4Ts as a pretest probability tool for HIT. | End of study. | |
| To validate the Chong scale as a tool to determine the post-test probability for HIT. | End of study. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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For this study, patients already admitted to the hospital whose physician suspects the presence of HIT will be recruited for this study. Specifically, the trigger for recruitment include patients who have a HIT antibody test ordered.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chee M Chan, MD | Contact | (202) 877-7856 | chee.m.chan@medstar.net |
| Name | Affiliation | Role |
|---|---|---|
| Chee M Chan, MD | Medstar Health Research Institute | Principal Investigator |
| Andrew F Shorr, MD, MPH | Medstar Health Research Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16634744 | Background | 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. | |
| 15225114 | Background | Chong BH, Chong JJ. Heparin-induced thrombocytopenia. Expert Rev Cardiovasc Ther. 2004 Jul;2(4):547-59. doi: 10.1586/14779072.2.4.547. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 19, 2020 | |
| Reset | Dec 16, 2020 | |
| Release | Dec 14, 2022 | |
| Reset | Oct 11, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 19, 2020 | Dec 16, 2020 | |||
| Dec 14, 2022 |
| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Serum will be collected to perform a serotonin release assay as confirmatory testing for the presence of HIT.
| Blood draw | Other | Patient serum will be collected to perform Serotonin Release Assay testing to verify the presence of HIT. |
|
| 25611568 | Derived | 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. |
| Oct 11, 2023 |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |