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Compressive Elastic Dressing Versus TR Band (Band Vs Gauze)

Primary Purpose

Coronary Artery Disease, Myocardial Infarction, Angina, Unstable

Status
Completed
Phase
Not Applicable
Locations
Palestinian Territory, occupied
Study Type
Interventional
Intervention
Compressive Elastic dressing for hemostasis in cardiac procedure using radial approach
Wristband TR band for hemostasis in cardiac procedure using radial approach
Sponsored by
An-Najah National University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Radial approach, Wristband, TR Band, compressive dressing, cardiac catheterization, radial artery, safeguard, randomized controlled trial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • An-Najah National University Hospital
  • An-Najah National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Compressive Elastic dressing

wristband TR Band

Arm Description

Patients who received compressive elastic dressing as a hemostasis technique after coronary angiography using radial approach.

Patients who received wristband TR Band as a hemostasis technique after coronary angiography using radial approach.

Outcomes

Primary Outcome Measures

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.
Number of patient with Hematoma and Grade of hematoma
It is defined by EASY hematoma scale.

Secondary Outcome Measures

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.
Ischemic changes to the hand
It is noted by clinical features of pallor, absence of pulse, pain, cold, paresthesia or paralysis.
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.
Number of patient with Radial Artery Occlusion on follow up
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
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.

Full Information

First Posted
June 4, 2022
Last Updated
September 27, 2022
Sponsor
An-Najah National University
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1. Study Identification

Unique Protocol Identification Number
NCT05409716
Brief Title
Compressive Elastic Dressing Versus TR Band
Acronym
Band Vs Gauze
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
May 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
An-Najah National University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
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.
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Compressive Elastic dressing
Arm Type
Experimental
Arm Description
Patients who received compressive elastic dressing as a hemostasis technique after coronary angiography using radial approach.
Arm Title
wristband TR Band
Arm Type
Active Comparator
Arm Description
Patients who received wristband TR Band as a hemostasis technique after coronary angiography using radial approach.
Intervention Type
Procedure
Intervention Name(s)
Compressive Elastic dressing for hemostasis in cardiac procedure using radial approach
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Wristband TR band for hemostasis in cardiac procedure using radial approach
Intervention Description
Following cardiac procedure using radial approach, hemostatic wristband TR BandR (Terumo Corporation, Tokyo, Japan) was utilized was used to achieve hemostasis.
Primary Outcome Measure Information:
Title
Compression "hemostasis" time
Description
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.
Time Frame
Up to 240 minutes after placement
Title
Number of patient with Hematoma and Grade of hematoma
Description
It is defined by EASY hematoma scale.
Time Frame
Within 24 hours after the procedure
Secondary Outcome Measure Information:
Title
Number of patient with Radial artery occlusion
Description
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.
Time Frame
Within 24 hours after the procedure
Title
Ischemic changes to the hand
Description
It is noted by clinical features of pallor, absence of pulse, pain, cold, paresthesia or paralysis.
Time Frame
Within 24 hours after the procedure
Title
Post-procedural pain
Description
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.
Time Frame
Within 24 hours after the procedure
Title
Number of patient with Radial Artery Occlusion on follow up
Description
Radial artery patency was checked by evaluating radial pulse and Doppler Ultrasonography.
Time Frame
After 4 weeks of the procedure.
Title
Patient satisfaction of the used compression methode Assessed by Likert scale for satisfaction
Description
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.
Time Frame
Within 24 hrs

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yunis A Daralammouri
Organizational Affiliation
An-Najah National University
Official's Role
Principal Investigator
Facility Information:
Facility Name
An-Najah National University Hospital
City
Nablus
State/Province
West Bank
ZIP/Postal Code
P4170051
Country
Palestinian Territory, occupied
Facility Name
An-Najah National University Hospital
City
Nablus
Country
Palestinian Territory, occupied

12. IPD Sharing Statement

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Compressive Elastic Dressing Versus TR Band

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