Comparison of 2 Hemostasis Techniques After Transradial Coronary

Coronary Artery Disease With Myocardial Infarction Clinical Trial

Official title:

Effect of Two Compression Devices on the Occurrence of Artery Occlusion After Transradial Cardiac Catheterization: Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02873871
• Other study ID #: 49237115.5.0000.5327.
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: December 2017

Study information

• Verified date: August 2020
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Disease With Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Device:
• Standardized compressive dressing
Standardized compressive dressing
• Hemostasis with TerumoBand®
Hemostasis with TerumoBand®

Locations

Country	Name	City	State
Brazil	Universidade Federal do Rio Grande do Sul - Post Graduated Program	Porto Alegre	Rio Grande Do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radial artery occlusion evaluated using Barbeau's test	test immediately after hemostasis compression device withdrawal	up to 3 hours
Secondary	Vascular complications	Clinical assesment	up to 3 hours
Secondary	Radial access site pain	standardized scale	up to 3 hours