Comparison of 2 Hemostasis Techniques After Transradial Coronary
Primary Purpose
Coronary Artery Disease With Myocardial Infarction
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Standardized compressive dressing
Hemostasis with TerumoBand®
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease With Myocardial Infarction
Eligibility Criteria
Inclusion Criteria:
- Adult patients submitted to elective or urgent coronary catheterization who presented with a A, B or C curve on oximetry test before the procedure
Exclusion Criteria:
- Inability to understand the study and sign the informed consent form
Sites / Locations
- Universidade Federal do Rio Grande do Sul - Post Graduated Program
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Control group
Intervention group
Arm Description
Standardized compressive dressing
Hemostasis with TerumoBand®
Outcomes
Primary Outcome Measures
Radial artery occlusion evaluated using Barbeau's test
test immediately after hemostasis compression device withdrawal
Secondary Outcome Measures
Vascular complications
Clinical assesment
Radial access site pain
standardized scale
Full Information
NCT ID
NCT02873871
First Posted
April 10, 2016
Last Updated
August 10, 2020
Sponsor
Hospital de Clinicas de Porto Alegre
1. Study Identification
Unique Protocol Identification Number
NCT02873871
Brief Title
Comparison of 2 Hemostasis Techniques After Transradial Coronary
Official Title
Effect of Two Compression Devices on the Occurrence of Artery Occlusion After Transradial Cardiac Catheterization: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Randomized clinical trial to compare radial artery patency after transradial coronary catheterization using 2 different hemostasis techniques. Patients submitted to diagnostic or therapeutic coronary catheterization will be prospectively enrolled in this single-center trial and will be randomized to radial hemostasis with TerumoBand® or a standardized compressive dressing with gauze and elastic bandage.
Detailed Description
Randomized clinical trial to compare radial artery patency after transradial coronary catheterization using 2 different hemostasis techniques. Patients submitted to diagnostic or therapeutic coronary catheterization will be prospectively enrolled in this single-center trial and will be randomized to radial hemostasis with TerumoBand® or a standardized compressive dressing with gauze and elastic bandage.
Interventions: Radial hemostasis with TerumoBand® and Radial hemostasis with a standardized compressive dressing
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease With Myocardial Infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Other
Arm Description
Standardized compressive dressing
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Hemostasis with TerumoBand®
Intervention Type
Device
Intervention Name(s)
Standardized compressive dressing
Intervention Description
Standardized compressive dressing
Intervention Type
Device
Intervention Name(s)
Hemostasis with TerumoBand®
Intervention Description
Hemostasis with TerumoBand®
Primary Outcome Measure Information:
Title
Radial artery occlusion evaluated using Barbeau's test
Description
test immediately after hemostasis compression device withdrawal
Time Frame
up to 3 hours
Secondary Outcome Measure Information:
Title
Vascular complications
Description
Clinical assesment
Time Frame
up to 3 hours
Title
Radial access site pain
Description
standardized scale
Time Frame
up to 3 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients submitted to elective or urgent coronary catheterization who presented with a A, B or C curve on oximetry test before the procedure
Exclusion Criteria:
Inability to understand the study and sign the informed consent form
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eneida Rejane Rabelo da Silva, RN, MSc, ScD
Organizational Affiliation
Hospital de Clinicas de Porto Alegre
Official's Role
Study Chair
Facility Information:
Facility Name
Universidade Federal do Rio Grande do Sul - Post Graduated Program
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90035003
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Comparison of 2 Hemostasis Techniques After Transradial Coronary
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