Clinical trial NCT05409716: Compressive Elastic Dressing Versus TR Band
Official title: Comparison Between Compressive Elastic Dressing and Hemostatic TR Band Following Cardiac Intervention Utilizing the Radial Technique: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: An-Najah National University
Sponsor class: OTHER
First posted: 2022-06-08
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Compression "hemostasis" time
timeFrame: Up to 240 minutes after placement
measure: Number of patient with Hematoma and Grade of hematoma
timeFrame: Within 24 hours after the procedure
Secondary outcomes:
measure: Number of patient with Radial artery occlusion
timeFrame: Within 24 hours after the procedure
measure: Ischemic changes to the hand
timeFrame: Within 24 hours after the procedure
measure: Post-procedural pain
timeFrame: Within 24 hours after the procedure
measure: Number of patient with Radial Artery Occlusion on follow up
timeFrame: After 4 weeks of the procedure.
measure: Patient satisfaction of the used compression methode Assessed by Likert scale for satisfaction
timeFrame: Within 24 hrs
Other outcomes:
Locations:
city: Nablus
country: Palestinian Territory, occupied
facility: An-Najah National University Hospital
state: West Bank
city: Nablus
country: Palestinian Territory, occupied
facility: An-Najah National University Hospital
Study officials:
affiliation: An-Najah National University
name: Yunis A Daralammouri
role: PRINCIPAL_INVESTIGATOR
References: