Heparin vs Placebo for Cardiac Catheterization

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

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

Study Overview

• Status: Recruiting
• Conditions: Cardiac Disease
• Intervention / Treatment: Drug: Placebos; Drug: Heparin

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.

• Study Type: Interventional
• Enrollment (Anticipated): 3600
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada
      • Not yet recruiting
      • Hamilton Health Sciences
    • London, Ontario, Canada, N6A5A5
      • Recruiting
      • London Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Low dose heparin; heparin (25 IU/Kg -maximal dose 3,000 IU)	Drug: Heparin; two doses of heparin
Active Comparator: High dose heparin; heparin 50 IU/kg -maximal dose 5,000 IU	Drug: Heparin; two doses of heparin
Placebo Comparator: Placebo; Normal saline 0.9%.	Drug: Placebos; placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
hematoma	>5 cm	1 hour
radial artery occlusion	by ultrasound	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
access site bleeding	any bleeding	1 hour
non access site bleeding	bleeding not related to access site, such as gastrointestinal	1 day
access site complications	pseudoaneurysm, arteriovenous fistula	1 day
wrist band duration	How long wrist band was on	3 hours
time to discharge	when patient was able to leave the post procedure care area	1 day

Collaborators and Investigators

• Sponsor: Lawson Health Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2020
• Primary Completion (Anticipated): August 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: April 30, 2020
• First Submitted That Met QC Criteria: May 1, 2020
• First Posted (Actual): May 5, 2020

Study Record Updates

• Last Update Posted (Actual): March 17, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Anticoagulants; Heparin
• Other Study ID Numbers: 2102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No