Band Vs Gauze: Compressive Elastic Dressing Versus TR Band

Sponsor

An-Najah National University (Other)

Overall Status

Completed

CT.gov ID

NCT05409716

Collaborator

(none)

400

Enrollment

Locations

Arms

Actual Duration (Months)

200

Patients Per Site

22.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	Procedure: Compressive Elastic dressing for hemostasis in cardiac procedure using radial approach Procedure: Wristband TR band for hemostasis in cardiac procedure using radial approach	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2020

Actual Primary Completion Date :

Jan 1, 2021

Actual Study Completion Date :

May 1, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Number of patient with Radial artery occlusion [Within 24 hours after the procedure]
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.

Secondary Outcome Measures

Compression "hemostasis" time [Up to 240 minutes after placement]
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.
Number of patient with Hematoma and Grade of hematoma [Within 24 hours after the procedure]
It is defined by EASY hematoma scale.
Ischemic changes to the hand [Within 24 hours after the procedure]
It is noted by clinical features of pallor, absence of pulse, pain, cold, paresthesia or paralysis.
Post-procedural pain [Within 24 hours after the procedure]
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.
Number of patient with Radial Artery Occlusion on follow up [After 4 weeks of the procedure.]
Radial artery patency was checked by evaluating radial pulse and Doppler Ultrasonography.
Patient satisfaction of the used compression methode Assessed by Likert scale for satisfaction [Within 24 hrs]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	An-Najah National University Hospital	Nablus	West Bank	Palestinian Territory, occupied	P4170051
2	An-Najah National University Hospital	Nablus		Palestinian Territory, occupied