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Heparin-Induced Thrombocytopenia Score Card Study

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00489437
Enrollment
536
Registered
2007-06-21
Start date
2007-12-31
Completion date
2013-02-28
Last updated
2013-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heparin-Induced Thrombocytopenia

Keywords

diagnosis

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.

Interventions

DEVICEID-PaGIA Heparin/PF4 antibody test

All patients have a 4T's Score completed, a same-day PaGIA performed and a Serotonin Release Assay performed.

PROCEDUREClinical Prediction Score-HIT Score Card

1. clinical prediction rule 2. rapid immunoassay

Sponsors

Heart and Stroke Foundation of Ontario
CollaboratorOTHER
McMaster University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026