Cardiac Disease
Conditions
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.
Interventions
DRUGHeparin
two doses of heparin
DRUGPlacebos
placebo
Sponsors
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| radial artery occlusion | 1 hour | by ultrasound |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hematoma> 5 cm | one hour post procedure | Hematoma at access site |
| access site bleeding | 1 hour | any bleeding |
| non access site bleeding | 1 day | bleeding not related to access site, such as gastrointestinal |
| access site complications | 1 day | pseudoaneurysm, arteriovenous fistula |
| wrist band duration | 3 hours | How long wrist band was on |
| time to discharge | 1 day | when patient was able to leave the post procedure care area |
Countries
Canada
Contacts
CONTACTShahar Lavi, MD
Outcome results
None listed