Compressive Elastic Dressing Versus TR Band (Band Vs Gauze)

An-Najah National University

Status: Completed

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

Treatments: Procedure: Wristband TR band for hemostasis in cardiac procedure using radial approach; Procedure: Compressive Elastic dressing for hemostasis in cardiac procedure using radial approach

Study type: Interventional

Funder types: Other

Identifiers

NCT05409716

TR-Band Vs Gauze Swab

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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400 participants in 2 patient groups

Compressive Elastic dressing

Experimental group

Description:

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

Treatment:

Procedure: Compressive Elastic dressing for hemostasis in cardiac procedure using radial approach

wristband TR Band

Active Comparator group

Description:

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

Treatment:

Procedure: Wristband TR band for hemostasis in cardiac procedure using radial approach