Back to resultsHeparin vs Placebo for Cardiac Catheterization
Primary Purpose
Cardiac Disease
Status
Recruiting
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Heparin
Placebos
Sponsored by
About this trial
This is an interventional prevention trial for Cardiac Disease
Eligibility Criteria
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
Sites / Locations
- Hamilton Health Sciences
- London Health Sciences CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Low dose heparin
High dose heparin
Placebo
Arm Description
heparin (25 IU/Kg -maximal dose 3,000 IU)
heparin 50 IU/kg -maximal dose 5,000 IU
Normal saline 0.9%.
Outcomes
Primary Outcome Measures
hematoma
>5 cm
radial artery occlusion
by ultrasound
Secondary Outcome Measures
access site bleeding
any bleeding
non access site bleeding
bleeding not related to access site, such as gastrointestinal
access site complications
pseudoaneurysm, arteriovenous fistula
wrist band duration
How long wrist band was on
time to discharge
when patient was able to leave the post procedure care area
Full Information
NCT ID
NCT04374799
First Posted
April 30, 2020
Last Updated
March 16, 2023
Sponsor
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT04374799
Brief Title
Heparin vs Placebo for Cardiac Catheterization
Official Title
A Randomized Trial of Heparin vs Placebo in Patients Undergoing Cardiac Catheterization Via the Trans-radial Approach
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 5, 2020 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Low dose heparin
Arm Type
Active Comparator
Arm Description
heparin (25 IU/Kg -maximal dose 3,000 IU)
Arm Title
High dose heparin
Arm Type
Active Comparator
Arm Description
heparin 50 IU/kg -maximal dose 5,000 IU
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal saline 0.9%.
Intervention Type
Drug
Intervention Name(s)
Heparin
Intervention Description
two doses of heparin
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
placebo
Primary Outcome Measure Information:
Title
hematoma
Description
>5 cm
Time Frame
1 hour
Title
radial artery occlusion
Description
by ultrasound
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
access site bleeding
Description
any bleeding
Time Frame
1 hour
Title
non access site bleeding
Description
bleeding not related to access site, such as gastrointestinal
Time Frame
1 day
Title
access site complications
Description
pseudoaneurysm, arteriovenous fistula
Time Frame
1 day
Title
wrist band duration
Description
How long wrist band was on
Time Frame
3 hours
Title
time to discharge
Description
when patient was able to leave the post procedure care area
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shahar Lavi, MD
Phone
519-6633611
Email
Shahar.lavi@lhsc.on.ca
Facility Information:
Facility Name
Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
Country
Canada
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shamir Mehta
First Name & Middle Initial & Last Name & Degree
Shamir Mehta, MD
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A5A5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shahar Lavi, MD
Phone
519-663-3611
Email
shahar.lavi@lhsc.on.ca
First Name & Middle Initial & Last Name & Degree
Cassandra Wagner, MSc
Phone
519-685-8500
Ext
35625
Email
cassandra.wagner@lhsc.on.ca
First Name & Middle Initial & Last Name & Degree
Shahar Lavi, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Heparin vs Placebo for Cardiac Catheterization
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