Comparaison d'un Traitement systématique à l'héparine Versus sélectif Pour la prévention de l'Occlusion Radiale EASY-Héparine
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- Rates of patent hemostasis
Study Overview
Brief Summary
Randomized study comparing the systematic use of heparin (standard of care) against an elective use of heparin to prevent radial artery occlusion after a percutaneous catheterization using a dual-artery compression system.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Any patient referred for a diagnostic transradial catheterism
Exclusion Criteria
- •Unable to understand study design or provide informed consent
- •Unable to receive antiplatelet therapy with aspirina and/or clopidogrel-prasugrel and/or ticagrelor and intravenous anticoagulant derived from heparine or bivalirudine
- •Local condition such as hematoma or pseudo-aneurims precluding radial or ulnar access.
- •Presence of plethysmographic waveform with simultaneous radial and ulnar occlusive compression (due to colaterals or interouseous artery) precluding the evaluation of patent hemostasis.
Arms & Interventions
Heparin
Standard of care with 70-100 IU/kg of heparin after a diagnostic only trans-radial catheterization and a dual-artery compression device for hemostasis.
No heparin
No heparin administered after diagnostic only trans-radial catheterization and a dual-artery compression device for hemostasis.
Intervention: No heparin (Other)
Outcomes
Primary Outcomes
Rates of patent hemostasis
Time Frame: within 24 hours after diagnostic angiography
Evaluation of patent hemostasis by pulse oximetry
Time to hemostasis
Time Frame: within 24 hours post-procedure
Nursing time involvement
Time Frame: within 24 hours post-procedure
Calculation of nursing time required for surveillance and care of hemostasis
Evaluation of complications
Time Frame: within 30 days of procedure
Compilation of access site complications such as radial artery occlusion, bleeding, presence and grading of hematomas, etc.
Secondary Outcomes
No secondary outcomes reported
Investigators
Olivier F. Bertrand
MD
Laval University