Compressive Elastic Dressing Versus TR Band

NCT05409716 | Completed DMC

• 1 other identifier: TR-Band Vs Gauze Swab
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

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

Keywords

Radial approach; Wristband; TR Band; compressive dressing; cardiac catheterization; radial artery; safeguard; randomized controlled trial

Outcome Measures

Primary Outcomes (2)

• Compression "hemostasis" time

  The time from the placement of the hemostatic Wristband or Compressive dressing until its removal (when there's no blood oozing after removal), measured by minutes.

  Up to 240 minutes after placement

• Number of patient with Hematoma and Grade of hematoma

  It is defined by EASY hematoma scale.

  Within 24 hours after the procedure

Secondary Outcomes (5)

• Number of patient with Radial artery occlusion

  Within 24 hours after the procedure

• Ischemic changes to the hand

  Within 24 hours after the procedure

• Post-procedural pain

  Within 24 hours after the procedure

• Number of patient with Radial Artery Occlusion on follow up

  After 4 weeks of the procedure.

• Patient satisfaction of the used compression methode Assessed by Likert scale for satisfaction

  Within 24 hrs

Study Arms (2)

Compressive Elastic dressing

EXPERIMENTAL

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

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

wristband TR Band

ACTIVE COMPARATOR

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

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

Interventions

Compressive Elastic dressing for hemostasis in cardiac procedure using radial approach 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.

Compressive Elastic dressing

Wristband TR band for hemostasis in cardiac procedure using radial approach PROCEDURE

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

wristband TR Band

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• An-Najah National University: lead

Study Sites (2)

An-Najah National University Hospital

Nablus, West Bank, P4170051, Palestinian Territories

Location

An-Najah National University Hospital

Nablus, Palestinian Territories

Location

MeSH Terms

Conditions

Coronary Artery Disease; Myocardial Infarction; Angina, Unstable; Angina, Stable; Acute Coronary Syndrome; ST Elevation Myocardial Infarction; Non-ST Elevated Myocardial Infarction; Myocardial Ischemia; Atherosclerosis; Chest Pain

Interventions

Hemostasis

Condition Hierarchy (Ancestors)

Coronary Disease; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Angina Pectoris; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Yunis A Daralammouri

  An-Najah National University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 4, 2022
• First Posted: June 8, 2022
• Study Start: August 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: May 1, 2021
• Last Updated: September 29, 2022

Record last verified: 2022-09

Locations

PA (2)