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Heparin-Induced Thrombocytopenia Score Card Study

Primary Purpose

Heparin-Induced Thrombocytopenia

Status
Completed
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
ID-PaGIA Heparin/PF4 antibody test
Clinical Prediction Score-HIT Score Card
Sponsored by
McMaster University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heparin-Induced Thrombocytopenia focused on measuring diagnosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Suspected heparin-induced thrombocytopenia

Exclusion Criteria:

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

Sites / Locations

  • Hamilton Health Sciences

Outcomes

Primary Outcome Measures

Proportion of patients with a low or intermediate 4T's Score and a negative ID-PaGIA assay result who have a positive SRA.

Secondary Outcome Measures

Full Information

First Posted
June 19, 2007
Last Updated
September 9, 2013
Sponsor
McMaster University
Collaborators
Heart and Stroke Foundation of Ontario
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1. Study Identification

Unique Protocol Identification Number
NCT00489437
Brief Title
Heparin-Induced Thrombocytopenia Score Card Study
Official Title
Improving the Diagnosis of Heparin-Induced Thrombocytopenia: Utility of the 4T's Score and Evaluation of New Rapid Assays
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
Heart and Stroke Foundation of Ontario

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heparin-Induced Thrombocytopenia
Keywords
diagnosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
536 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
ID-PaGIA Heparin/PF4 antibody test
Intervention Description
All patients have a 4T's Score completed, a same-day PaGIA performed and a Serotonin Release Assay performed.
Intervention Type
Procedure
Intervention Name(s)
Clinical Prediction Score-HIT Score Card
Intervention Description
clinical prediction rule rapid immunoassay
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Suspected heparin-induced thrombocytopenia Exclusion Criteria: Unable to give consent Unable to provide a blood sample Previous entered in study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lori-Ann Linkins, MD, MSc
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C3
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25926600
Citation
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.
Results Reference
derived

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Heparin-Induced Thrombocytopenia Score Card Study

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