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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
Hospital de Clinicas de Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease With Myocardial Infarction

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 10, 2016
Last Updated
August 10, 2020
Sponsor
Hospital de Clinicas de Porto Alegre
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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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