Comparison of 2 Hemostasis Techniques After Transradial Coronary

Not Applicable

Completed

• Conditions: Coronary Artery Disease With Myocardial Infarction
• Interventions: Device: Standardized compressive dressing; Device: Hemostasis with TerumoBand®

• Registration Number: NCT02873871
• Lead Sponsor: Hospital de Clinicas de Porto Alegre

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

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2016-04-10
• Study First Submitted QC: 2016-08-16
• Study First Posted: 2016-08-22
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-10
• Last Update Posted: 2020-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Standardized compressive dressing	Standardized compressive dressing
Intervention group	Hemostasis with TerumoBand®	Hemostasis with TerumoBand®

Primary Outcome Measures

Name	Time	Method
Radial artery occlusion evaluated using Barbeau's test	up to 3 hours	test immediately after hemostasis compression device withdrawal

Secondary Outcome Measures

Name	Time	Method
Radial access site pain	up to 3 hours	standardized scale
Vascular complications	up to 3 hours	Clinical assesment

Trial Locations

Locations (1)

Universidade Federal do Rio Grande do Sul - Post Graduated Program; 🇧🇷 Porto Alegre, Rio Grande Do Sul, Brazil