Compressive Elastic Dressing Versus TR Band

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

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-05-01

Brief Summary

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Radial approach is widely established in cardiac diagnostic and therapeutic treatments. It has been shown to decrease bleeding, vascular problems, and mortality rates when compared to the femoral approach. It also offers better comfort to patients through early mobility and lowers hospital expenses.

Previously, there were no specific devices for radial artery hemostasis. Many different types of dressings were used in various hospitals with no standardization. This raises the question of whether specific devices surpass dressings in terms of patient comfort, time required to maintain hemostasis, and vascular complications.

The primary goal of this study was to examine the effectiveness of compression dressings and hemostatic wristbands on patients undergoing cardiac procedures via radial approach in terms of patient comfort, time required to maintain hemostasis, and vascular problems.

The hemostatic wristband TR BandR (Terumo Corporation, Tokyo, Japan) was utilized in one group, while compressive elastic dressing, standardized as 13 threads gauze overlapped, opened, longitudinally pleated once and wrapped, making a 5-cm long cylinder, 1-cm in height, was used in the other.

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Detailed Description

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Conditions

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Coronary Artery Disease Myocardial Infarction Angina, Unstable Angina, Stable Acute Coronary Syndrome STEMI NSTEMI Ischemic Heart Disease Atherosclerotic Cardiovascular Disease Chest Pain Non ST Elevation Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Patients enrolled to the study were randomized into TR Band or compressive dressing groups. Care providers operated on patients and investigators collected their data during and after the operation. The independent variable - Hemostasis technique (TR Band or compressive dressing ) - was coded into X or Z groups, then data was sent to the outcomes assessor.

Study Groups

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Compressive Elastic dressing

Patients who received compressive elastic dressing as a hemostasis technique after coronary angiography using radial approach.

Group Type EXPERIMENTAL

Compressive Elastic dressing for hemostasis in cardiac procedure using radial approach

Intervention Type PROCEDURE

Following cardiac procedure using radial approach, compressive elastic dressing, standardized as 13 threads gauze overlapped, opened, longitudinally pleated once and wrapped, making a 5-cm long cylinder, 1-cm in height, fixed with elastic crepe bandage was used to achieve hemostasis.

wristband TR Band

Patients who received wristband TR Band as a hemostasis technique after coronary angiography using radial approach.

Group Type ACTIVE_COMPARATOR

Wristband TR band for hemostasis in cardiac procedure using radial approach

Intervention Type PROCEDURE

Following cardiac procedure using radial approach, hemostatic wristband TR BandR (Terumo Corporation, Tokyo, Japan) was utilized was used to achieve hemostasis.

Interventions

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Compressive Elastic dressing for hemostasis in cardiac procedure using radial approach

Following cardiac procedure using radial approach, compressive elastic dressing, standardized as 13 threads gauze overlapped, opened, longitudinally pleated once and wrapped, making a 5-cm long cylinder, 1-cm in height, fixed with elastic crepe bandage was used to achieve hemostasis.

Intervention Type PROCEDURE

Wristband TR band for hemostasis in cardiac procedure using radial approach

Following cardiac procedure using radial approach, hemostatic wristband TR BandR (Terumo Corporation, Tokyo, Japan) was utilized was used to achieve hemostasis.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age \> 18 years
* Patients who agree to participate in the study and sign the consent form.
* Patients with an indication for coronary catheterization
* Clinically stable patients
* Patients with palpable pulses on at least one of the radial arteries.

Exclusion Criteria

* Patients who are hemodynamically unstable (systolic blood pressure less 90mmhg)
* Patients with radial AV shunt for hemodialysis
* Patients with previous CABG using radial artery
* Patients with Renaud phenomenon or lymphedema
* Patients who had vascular problems at the puncture site before the hemostasis process started.
* Failure to obtain radial access

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No