Heparin-Induced Thrombocytopenia Score Card Study
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Purpose
Main Research Question:
Can two new types of test, one called the 4T's score and the other called a rapid assay, help doctors correctly identify which patients are unlikely to have heparin-induced thrombocytopenia (HIT)?
HIT is a severe allergic reaction to the blood thinner heparin. This allergic reaction can lead to heart attacks, strokes, limb amputations, and death. Because heparin is one of the most commonly used drugs in the hospital setting, it is very important that the investigators are able to correctly identify who can safely continue to take heparin and who cannot.
It can be very difficult to diagnose HIT because it can look like many other medical conditions and the best laboratory tests for HIT are difficult to run and only available at specialized centres.
It would be very helpful if doctors had tests they could use that would tell them quickly and accurately which patients with symptoms that look like HIT really do have HIT (and require urgent treatment with another type of blood thinner) and which patients are very unlikely to have HIT (and could continue to take heparin safely). In this study, the investigators will compare the 4T's score (a scoring system that assigns "points" to the presence or absence of specific clinical features) and a rapid laboratory test with the old laboratory test to find out if one or both of these types of tests are useful for telling doctors which patients have HIT and which patients don't have HIT.
| Condition | Intervention | Phase |
|---|---|---|
|
Heparin-Induced Thrombocytopenia |
Device: ID-PaGIA Heparin/PF4 antibody test Procedure: Clinical Prediction Score-HIT Score Card |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Improving the Diagnosis of Heparin-Induced Thrombocytopenia: Utility of the 4T's Score and Evaluation of New Rapid Assays |
- Proportion of patients with a low or intermediate 4T's Score and a negative ID-PaGIA assay result who have a positive SRA. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 538 |
| Study Start Date: | December 2007 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
-
Device: ID-PaGIA Heparin/PF4 antibody test
- clinical prediction rule
- rapid immunoassay
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Suspected heparin-induced thrombocytopenia
Exclusion Criteria:
- Unable to give consent
- Unable to provide a blood sample
- Previous entered in study
Contacts and Locations| Contact: Lori-Ann Linkins, MD, MSc | 905-527-4322 ext 43935 | linkinla@mcmaster.ca |
| Contact: Theodore E Warkentin, MD | 905-527-0271 ext 46139 | twarken@mcmaster.ca |
| Canada, Ontario | |
| Hamilton Health Sciences | Recruiting |
| Hamilton, Ontario, Canada, L8V 1C3 | |
| Principal Investigator: Lori-Ann Linkins, MD, MSc | |
| Principal Investigator: Theodore E Warkentin, MD | |
| Principal Investigator: | Lori-Ann Linkins, MD, MSc | McMaster University |
More Information
No publications provided
| Responsible Party: | McMaster University |
| ClinicalTrials.gov Identifier: | NCT00489437 History of Changes |
| Other Study ID Numbers: | HHS06-451 |
| Study First Received: | June 19, 2007 |
| Last Updated: | May 11, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by McMaster University:
|
diagnosis |
Additional relevant MeSH terms:
|
Thrombocytopenia Blood Platelet Disorders Hematologic Diseases Calcium heparin Heparin Anticoagulants Hematologic Agents |
Therapeutic Uses Pharmacologic Actions Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents |
ClinicalTrials.gov processed this record on May 23, 2013