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Heparin-Induced Thrombocytopenia Score Card Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00489437
Recruitment Status : Completed
First Posted : June 21, 2007
Last Update Posted : September 10, 2013
Heart and Stroke Foundation of Ontario
Information provided by (Responsible Party):
McMaster University

Brief Summary:

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 or disease Intervention/treatment Phase
Heparin-Induced Thrombocytopenia Device: ID-PaGIA Heparin/PF4 antibody test Procedure: Clinical Prediction Score-HIT Score Card Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 536 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : December 2007
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Thinners

Intervention Details:
  • Device: ID-PaGIA Heparin/PF4 antibody test
    All patients have a 4T's Score completed, a same-day PaGIA performed and a Serotonin Release Assay performed.
  • Procedure: Clinical Prediction Score-HIT Score Card
    1. clinical prediction rule
    2. rapid immunoassay

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00489437

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Canada, Ontario
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 1C3
Sponsors and Collaborators
McMaster University
Heart and Stroke Foundation of Ontario
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Principal Investigator: Lori-Ann Linkins, MD, MSc McMaster University

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: McMaster University Identifier: NCT00489437     History of Changes
Other Study ID Numbers: HHS06-451
First Posted: June 21, 2007    Key Record Dates
Last Update Posted: September 10, 2013
Last Verified: September 2013

Keywords provided by McMaster University:

Additional relevant MeSH terms:
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Blood Platelet Disorders
Hematologic Diseases
Calcium heparin
Immunologic Factors
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action