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Completed

NCT Number: NCT02873871

Comparison of 2 Hemostasis Techniques After Transradial Coronary

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.

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Key information

Conditions

Coronary Artery Disease With Myocardial Infarction Coronary Artery Disease, Autosomal Dominant, 1

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal do Rio Grande do Sul - Post Graduated Program

Porto Alegre, Rio Grande do Sul, 90035003, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standardized compressive dressing

Device

Standardized compressive dressing

Hemostasis with TerumoBand®

Device

Hemostasis with TerumoBand®

Primary outcomes

  1. Radial artery occlusion evaluated using Barbeau's test

    Time frame: up to 3 hours

    test immediately after hemostasis compression device withdrawal

Secondary outcomes

  1. Vascular complications

    Time frame: up to 3 hours

    Clinical assesment

  2. Radial access site pain

    Time frame: up to 3 hours

    standardized scale

Sponsors and collaborators

Lead sponsor

Hospital de Clinicas de Porto Alegre

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Aug 22, 2016
Registry last updated
Aug 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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