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Completed

NCT Number: NCT05409716

Compressive Elastic Dressing Versus TR Band

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.

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Key information

Conditions

Coronary Artery Disease Acute Coronary Syndrome Angina Pectoris Angina, Stable Angina, Unstable Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Atherosclerotic Cardiovascular Disease Cardiovascular Diseases Chest Pain Coronary Disease Heart Diseases Infarction Ischemia Ischemic Heart Disease Myocardial Infarction Myocardial Ischemia NSTEMI Necrosis Neurologic Manifestations Non ST Elevation Myocardial Infarction Non-ST Elevated Myocardial Infarction Pain Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction STEMI Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

An-Najah National University Hospital, Nablus, West Bank, Palestinian Territories

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Compression "hemostasis" time

    Time frame: 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.

  2. Number of patient with Hematoma and Grade of hematoma

    Time frame: Within 24 hours after the procedure

    It is defined by EASY hematoma scale.

Secondary outcomes

  1. Number of patient with Radial artery occlusion

    Time frame: 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.

  2. Ischemic changes to the hand

    Time frame: Within 24 hours after the procedure

    It is noted by clinical features of pallor, absence of pulse, pain, cold, paresthesia or paralysis.

  3. Post-procedural pain

    Time frame: 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.

  4. Number of patient with Radial Artery Occlusion on follow up

    Time frame: After 4 weeks of the procedure.

    Radial artery patency was checked by evaluating radial pulse and Doppler Ultrasonography.

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

An-Najah National University

Other

Registry information

Official study title

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

Acronym: Band Vs Gauze

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 8, 2022
Registry last updated
Sep 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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