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Heparin-Induced Thrombocytopenia Score Card Study

NCT00489437 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 536

Last updated 2013-09-10

No results posted yet for this study

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.

Conditions

  • Heparin-Induced Thrombocytopenia

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Lori-Ann Linkins, MD, MSc · McMaster University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00489437 on ClinicalTrials.gov