Comparing Heparin and Placebo in Patients Undergoing Cardiac Catheterization
A Randomized Trial of Heparin vs Placebo in Patients Undergoing Cardiac Catheterization Via the Trans-radial Approach
PHASE3 · London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · NCT04374799
This study is testing whether different doses of heparin can help prevent complications like bruising and artery blockage in patients getting a heart procedure through their wrist.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1623 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's (other) |
| Locations | 2 sites (Hamilton, Ontario and 1 other locations) |
| Trial ID | NCT04374799 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of different doses of heparin compared to a placebo in patients undergoing diagnostic cardiac catheterization via the trans-radial approach. Participants will be randomly assigned to receive either low-dose heparin, high-dose heparin, or a saline placebo. The study aims to assess the incidence of hematoma and radial artery occlusion following the procedure. By evaluating these outcomes, the trial seeks to determine the optimal anticoagulation strategy for this patient population.
Who should consider this trial
Good fit: Ideal candidates include patients scheduled for diagnostic cardiac catheterization with a small size sheath and normal ulno-palmar circulation.
Not a fit: Patients with abnormal ulno-palmar circulation, prior radial artery thrombosis, or those requiring anticoagulation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved safety and outcomes for patients undergoing cardiac catheterization.
How similar studies have performed: Other studies have explored anticoagulation strategies in cardiac procedures, suggesting potential benefits, but this specific approach is being tested for the first time.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * diagnostic cardiac catheterization; Small size sheath; patency of the ulno-palmar circulation Exclusion Criteria: abnormal ulno-palmar circulation; Prior radial artery thrombosis; Prior surgery close to the access site; Emergent cardiac catheterization; History of HIT or allergy to heparin; Patients requiring anticoagulation
Where this trial is running
Hamilton, Ontario and 1 other locations
- Hamilton Health Sciences — Hamilton, Ontario, Canada (RECRUITING)
- London Health Sciences Centre — London, Ontario, Canada (RECRUITING)
Study contacts
- Study coordinator: Shahar Lavi, MD
- Email: Shahar.lavi@lhsc.on.ca
- Phone: 519-6633611
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cardiac Disease