Heparin-Induced Thrombocytopenia Score Card Study

NCT00489437 | Completed Phase 1 DMC

• 1 other identifier: HHS06-451
• Study Type: interventional
• Target: 536
• Locations: 1 country
• Sites: 1

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.

Conditions

Heparin-Induced Thrombocytopenia

Keywords

diagnosis

Outcome Measures

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.

  30 days

Interventions

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

1. clinical prediction rule 2. rapid immunoassay

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suspected heparin-induced thrombocytopenia

You may not qualify if:

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

Sponsors & Collaborators

• McMaster University: lead
• Heart and Stroke Foundation of Ontario: collaborator

Study Sites (1)

Hamilton Health Sciences

Hamilton, Ontario, L8V 1C3, Canada

Location

Related Publications (1)

• Linkins LA, Bates SM, Lee AY, Heddle NM, Wang G, Warkentin TE. Combination of 4Ts score and PF4/H-PaGIA for diagnosis and management of heparin-induced thrombocytopenia: prospective cohort study. Blood. 2015 Jul 30;126(5):597-603. doi: 10.1182/blood-2014-12-618165. Epub 2015 Apr 29.

  PMID: 25926600 DERIVED

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Lori-Ann Linkins, MD, MSc

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2007
• First Posted: June 21, 2007
• Study Start: December 1, 2007
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: September 10, 2013

Record last verified: 2013-09

Locations

CA (1)