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Completed

NCT Number: NCT00489437

Heparin-Induced Thrombocytopenia Score Card Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hamilton Health Sciences

Hamilton, Ontario, L8V 1C3, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Suspected heparin-induced thrombocytopenia

Exclusion criteria

  • Unable to give consent
  • Unable to provide a blood sample
  • Previous entered in study

Treatment and study plan

ID-PaGIA Heparin/PF4 antibody test

Device

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

Clinical Prediction Score-HIT Score Card

Procedure
  • clinical prediction rule
  • rapid immunoassay

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Heart and Stroke Foundation of Ontario

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2013
Study completion
2013
First posted
Jun 21, 2007
Registry last updated
Sep 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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