Compressive Elastic Dressing Versus TR Band (Band Vs Gauze)

Comparison Between Compressive Elastic Dressing and Hemostatic TR Band Following Cardiac Intervention Utilizing the Radial Technique: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction; Coronary Artery Disease; Chest Pain; Angina, Stable; Acute Coronary Syndrome; Ischemic Heart Disease; Angina, Unstable; Atherosclerotic Cardiovascular Disease; Non ST Elevation Myocardial Infarction; STEMI; NSTEMI
• Intervention / Treatment: Procedure: Compressive Elastic dressing for hemostasis in cardiac procedure using radial approach; Procedure: Wristband TR band for hemostasis in cardiac procedure using radial approach

• Study Type: Interventional
• Enrollment (Actual): 400
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Palestinian Territory, occupied
  • Nablus, Palestinian Territory, occupied
    • An-Najah National University Hospital
  • West Bank
    • Nablus, West Bank, Palestinian Territory, occupied, P4170051
      • An-Najah National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Compressive Elastic dressing; 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; 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.
Active Comparator: wristband TR Band; 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; Following cardiac procedure using radial approach, hemostatic wristband TR BandR (Terumo Corporation, Tokyo, Japan) was utilized was used to achieve hemostasis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patient with Radial artery occlusion	Radial artery patency was checked by evaluating radial pulse, capillary refill, hand color, temperature, and assessing the puncture site and hand for any hematoma or bleeding. In the event of an access site hematoma or any other ischemia sign, the patient will be sent to the radiology department for further assessment with radial artery Doppler.	Within 24 hours after the procedure
Ischemic changes to the hand	It is noted by clinical features of pallor, absence of pulse, pain, cold, paresthesia or paralysis.	Within 24 hours after the procedure
Post-procedural pain	Assessed by numerical rating scale (NRS) for pain, which is an 11 point subjective scale (0-10) where 0 refers for no pain, 1-3 for mild pain, 4-6 for moderate pain and 7-10 for severe pain.	Within 24 hours after the procedure
Number of patient with Radial Artery Occlusion on follow up	Radial artery patency was checked by evaluating radial pulse and Doppler Ultrasonography.	After 4 weeks of the procedure.
Patient satisfaction of the used compression methode Assessed by Likert scale for satisfaction	Assessed by Likert scale for satisfaction , which is a 5 point subjective scale (1-5) where 1 refers for Not at all satisfied , 2 for slightly satisfied , 3 for moderately satisfied, 4 for Very satisfied and 5 for Extremely satisfied.	Within 24 hrs

Collaborators and Investigators

• Sponsor: An-Najah National University
• Investigators: Principal Investigator: Yunis A Daralammouri, An-Najah National University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): January 1, 2021
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: June 4, 2022
• First Submitted That Met QC Criteria: June 7, 2022
• First Posted (Actual): June 8, 2022

Study Record Updates

• Last Update Posted (Actual): September 29, 2022
• Last Update Submitted That Met QC Criteria: September 27, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: randomized controlled trial; TR Band; cardiac catheterization; Wristband; radial artery; Radial approach; compressive dressing; safeguard
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pain; Neurologic Manifestations; Coronary Disease; Myocardial Infarction; Infarction; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Cardiovascular Diseases; Chest Pain; Atherosclerosis; Acute Coronary Syndrome; Angina Pectoris; Angina, Stable; Angina, Unstable; Non-ST Elevated Myocardial Infarction; Coagulants; Hemostatics
• Other Study ID Numbers: TR-Band Vs Gauze Swab

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No