Heparin-Induced Thrombocytopenia Score Card Study

Heparin-Induced Thrombocytopenia Clinical Trial

Official title:

Improving the Diagnosis of Heparin-Induced Thrombocytopenia: Utility of the 4T's Score and Evaluation of New Rapid Assays

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00489437
• Other study ID #: HHS06-451
• Status: Completed
• Phase: Phase 1
• First received: June 19, 2007
• Last updated: September 9, 2013
• Start date: December 2007
• Est. completion date: February 2013

Study information

• Verified date: September 2013
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 536
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Suspected heparin-induced thrombocytopenia

Exclusion Criteria:

• Unable to give consent

• Unable to provide a blood sample

• Previous entered in study

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Heparin-Induced Thrombocytopenia
• Thrombocytopenia
• Thrombocytosis

Intervention

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
clinical prediction rule rapid immunoassay

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Heart and Stroke Foundation of Ontario

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with a low or intermediate 4T's Score and a negative ID-PaGIA assay result who have a positive SRA.		30 days	Yes