Recruiting

Observational Study

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT03148912

Conditions

Heparin-induced Thrombocytopenia (HIT)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Diagnostic algorithm

Study Details

Brief summary:

Multicentre (Ottawa and Halifax) prospective cohort study using a diagnostic approach in patients clinically suspected to have HIT that combines pretest probability assessment with quantitative interpretation of anti-PF4 assay.

Conditions

Heparin-induced Thrombocytopenia (HIT)

Study ID

NCT03148912

Start date

Nov 23, 2018

Status verified date

Feb, 2021

Completion date

Dec, 2022

Anticipated

Primary completion date

Dec, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Patient with clinical suspicion of HIT by treating physician

Exclusion Criteria:

1. Less than 18 years of age;
2. Prior diagnosis of HIT ever;
3. Patient enrolled within preceding 100 days;
4. Functional/ confirmatory platelet activation results available at the time of enrollment;
5. Requiring cardio-pulmonary bypass or percutaneous cardiac angioplasty or any other cardiac or vascular surgery/procedure requiring intra-operative/procedural heparin administration planned within 30 days;
6. Unable to complete study follow up;
7. Unable to obtain consent (or proxy consent from substitute decision maker where applicable);
8. Life expectancy less than 30 days;
9. Greater than 72 hours from clinical suspicion of HIT and/or request for HIT anti-PF4 ELISA testing.

Study Design

Enrollment

180 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: diagnostic algorithm

Optimizing the interpretation of the more readily available anti-PF4 assay would reduce the reliance on functional testing/ confirmatory testing (Serotonin Release Assay, SRA) and the number of patients exposed to unnecessary changes in anticoagulation therapy while awaiting the timely functional test results

Interventions

Diagnostic algorithm

The treating physician will complete an enrollment assessment including the 4T score pretest probability assessment14. All patients will have laboratory testing for HIT anti-PF4 as well as SRA testing. Results of the anti-PF4 assay (OD value) will be available to the treating physician who will be instructed to follow the study diagnostic algorithm

Primary outcome measure

  • Recruitment [ Time Frame: 2 years ]
  • False negative management failures [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Chantal Rockwell, BA

613-737-8899crockwell@ohri.ca

Locations

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada, KIH 8L6

Contacts

Lisa Duffett, MSc., MD

613-737-8899lduffett@toh.ca

Chantal Rockwell, BA

613-737-8899crockwell@ohri.ca

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Feb 24, 2021

Last verified

Feb, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2021-02-24.