Heparin-Induced Thrombocytopenia Score Card Study

This study has been completed.
Sponsor:
Collaborator:
Heart and Stroke Foundation of Ontario
Information provided by (Responsible Party):
McMaster University
ClinicalTrials.gov Identifier:
NCT00489437
First received: June 19, 2007
Last updated: September 9, 2013
Last verified: September 2013
  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

Resource links provided by NLM:


Further study details as provided by McMaster University:

Primary Outcome Measures:
  • 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 ]

Enrollment: 536
Study Start Date: December 2007
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00489437

Locations
Canada, Ontario
Hamilton Health Sciences
Hamilton, Ontario, Canada, L8V 1C3
Sponsors and Collaborators
McMaster University
Heart and Stroke Foundation of Ontario
Investigators
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: September 9, 2013
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 April 17, 2014