Compressive Elastic Dressing Versus TR Band

Not Applicable

Completed

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

• Registration Number: NCT05409716
• Lead Sponsor: An-Najah National University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-08-01
• Primary Completion: 2021-01-01
• Study Completion: 2021-05-01
• Study First Submitted: 2022-06-04
• Study First Submitted QC: 2022-06-07
• Study First Posted: 2022-06-08
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-27
• Last Update Posted: 2022-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Compressive Elastic dressing	Compressive Elastic dressing for hemostasis in cardiac procedure using radial approach	Patients who received compressive elastic dressing as a hemostasis technique after coronary angiography using radial approach.
wristband TR Band	Wristband TR band for hemostasis in cardiac procedure using radial approach	Patients who received wristband TR Band as a hemostasis technique after coronary angiography using radial approach.

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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	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.
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.
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.
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.

Trial Locations

Locations (1)

An-Najah National University Hospital; 🇵🇸 Nablus, Palestinian Territory, occupied