Comparison of 2 Hemostasis Techniques After Transradial Coronary

NCT ID: NCT02873871

Last Updated: 2020-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2017-12-31

Brief Summary

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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

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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

Conditions

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Coronary Artery Disease With Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

Standardized compressive dressing

Group Type OTHER

Standardized compressive dressing

Intervention Type DEVICE

Standardized compressive dressing

Intervention group

Hemostasis with TerumoBand®

Group Type EXPERIMENTAL

Hemostasis with TerumoBand®

Intervention Type DEVICE

Hemostasis with TerumoBand®

Interventions

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Standardized compressive dressing

Standardized compressive dressing

Intervention Type DEVICE

Hemostasis with TerumoBand®

Hemostasis with TerumoBand®

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital de Clinicas de Porto Alegre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eneida Rejane Rabelo da Silva, RN, MSc, ScD

Role: STUDY_CHAIR

Hospital de Clinicas de Porto Alegre

Locations

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Universidade Federal do Rio Grande do Sul - Post Graduated Program

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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49237115.5.0000.5327.

Identifier Type: -

Identifier Source: org_study_id

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