Heparin vs Placebo for Cardiac Catheterization

• Sponsor: Lawson Health Research Institute (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04374799
• Collaborator: (none)
• Enrollment: 3,600
• Locations: 2
• Arms: 3
• Anticipated Duration (Months): 49.9
• Patients Per Site: 1800
• Patients Per Site Per Month: 36.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Cardiac Disease	Drug: Heparin; Drug: Placebos	Phase 3

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 3600 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Randomized Trial of Heparin vs Placebo in Patients Undergoing Cardiac Catheterization Via the Trans-radial Approach
• Actual Study Start Date: Oct 5, 2020
• Anticipated Primary Completion Date: Aug 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. hematoma [1 hour]

   >5 cm

2. radial artery occlusion [1 hour]

   by ultrasound

Secondary Outcome Measures

1. access site bleeding [1 hour]

   any bleeding

2. non access site bleeding [1 day]

   bleeding not related to access site, such as gastrointestinal

3. access site complications [1 day]

   pseudoaneurysm, arteriovenous fistula

4. wrist band duration [3 hours]

   How long wrist band was on

5. time to discharge [1 day]

   when patient was able to leave the post procedure care area

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hamilton Health Sciences	Hamilton	Ontario	Canada
2	London Health Sciences Centre	London	Ontario	Canada	N6A5A5

Sponsors and Collaborators

• Lawson Health Research Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lawson Health Research Institute
• ClinicalTrials.gov Identifier: NCT04374799
• Other Study ID Numbers: 2102
• First Posted: May 5, 2020
• Last Update Posted: Oct 8, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Heart Diseases; Heparin

Study Results

No Results Posted as of Oct 8, 2020