Heparin vs Placebo for Cardiac Catheterization
- Registration Number
- NCT04374799
- Lead Sponsor
- Lawson Health Research Institute
- Brief Summary
Patients undergoing cardiac catheterization will be randomized to 3 groups: no anticoagulant, low dose anticoagulant and high dose anticoagulant.
- Detailed Description
Patients undergoing diagnostic cardiac catheterization via the trans-radial approach will be randomly allocated (1:1:1) to receive either low-dose UFH (25 IU/Kg -maximal dose 3,000 IU), high-dose UFH 50 IU/kg -maximal dose 5,000 IU) or N/S 0.9%. After 30 minutes, patients will undergo a gradual wrist band release. Hematoma and radial artery occlusion will be assessed.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3600
- diagnostic cardiac catheterization; Small size sheath; patency of the ulno-palmar circulation
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Low dose heparin Heparin heparin (25 IU/Kg -maximal dose 3,000 IU) Placebo Placebos Normal saline 0.9%. High dose heparin Heparin heparin 50 IU/kg -maximal dose 5,000 IU
- Primary Outcome Measures
Name Time Method radial artery occlusion 1 hour by ultrasound
hematoma 1 hour \>5 cm
- Secondary Outcome Measures
Name Time Method access site bleeding 1 hour any bleeding
time to discharge 1 day when patient was able to leave the post procedure care area
access site complications 1 day pseudoaneurysm, arteriovenous fistula
wrist band duration 3 hours How long wrist band was on
non access site bleeding 1 day bleeding not related to access site, such as gastrointestinal
Trial Locations
- Locations (2)
Hamilton Health Sciences
🇨🇦Hamilton, Ontario, Canada
London Health Sciences Centre
🇨🇦London, Ontario, Canada