Heparin vs Placebo for Cardiac Catheterization

Cardiac Disease Clinical Trial

Official title:

A Randomized Trial of Heparin vs Placebo in Patients Undergoing Cardiac Catheterization Via the Trans-radial Approach

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04374799
• Other study ID #: 2102
• Status: Recruiting
• Phase: Phase 3
• Start date: October 5, 2020
• Est. completion date: December 2025

Study information

• Verified date: March 2023
• Source: Lawson Health Research Institute
• Contact: Shahar Lavi, MD
• Phone: 519-6633611
• Email: Shahar.lavi[@]lhsc.on.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients undergoing cardiac catheterization will be randomized to 3 groups: no anticoagulant, low dose anticoagulant and high dose anticoagulant.

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 information / eligibility

• Status: Recruiting
• Enrollment: 3600
• Est. completion date: December 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Disease
• Heart Diseases

Intervention

Drug:
• Heparin
two doses of heparin
• Placebos
placebo

Locations

Country	Name	City	State
Canada	Hamilton Health Sciences	Hamilton	Ontario
Canada	London Health Sciences Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hematoma	>5 cm	1 hour
Primary	radial artery occlusion	by ultrasound	1 hour
Secondary	access site bleeding	any bleeding	1 hour
Secondary	non access site bleeding	bleeding not related to access site, such as gastrointestinal	1 day
Secondary	access site complications	pseudoaneurysm, arteriovenous fistula	1 day
Secondary	wrist band duration	How long wrist band was on	3 hours
Secondary	time to discharge	when patient was able to leave the post procedure care area	1 day