Coronary Artery DiseaseBand Vs GauzeNCT05409716
Compressive Elastic Dressing Versus TR Band
A study testing Compressive Elastic dressing for hemostasis in cardiac procedure using radial approach and Wristband TR band for hemostasis in cardiac procedure using radial approach in people with Coronary Artery Disease and Myocardial Infarction, run by An-Najah National University at 2 sites in Palestinian Territories.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Myocardial Infarction, Angina, Unstable
- What is being tested?
- Compressive Elastic dressing for hemostasis in cardiac procedure using radial approach and Wristband TR band for hemostasis in cardiac procedure using radial approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesPalestinian Territories
- Study dates
- 1 Aug 2020to 1 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Palestinian Territories2 sites
An-Najah National University Hospital
Nablus, West Bank, P4170051
An-Najah National University Hospital
Nablus
About this study
Official title: Comparison Between Compressive Elastic Dressing and Hemostatic TR Band Following Cardiac Intervention Utilizing the Radial Technique: A Randomized Controlled Trial
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.
Read more
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.
- Conditions
- Coronary Artery Disease, Myocardial Infarction, Angina, Unstable, Angina, Stable, Acute Coronary Syndrome, STEMI
- Being tested
- Compressive Elastic dressing for hemostasis in cardiac procedure using radial approach, Wristband TR band for hemostasis in cardiac procedure using radial approach
- Keywords
- Radial approach, Wristband, TR Band, compressive dressing, cardiac catheterization, radial artery, safeguard, randomized controlled trial
- Medical subject headings
- Coronary Artery Disease, Myocardial Infarction, Angina, Unstable, Angina, Stable, Acute Coronary Syndrome, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compressive Elastic dressing for hemostasis in cardiac procedure using radial approachProcedure or surgery
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 approachProcedure or surgery
Following cardiac procedure using radial approach, hemostatic wristband TR BandR (Terumo Corporation, Tokyo, Japan) was utilized was used to achieve hemostasis.
| Study group | Role | What they receive |
|---|---|---|
| Compressive Elastic dressing | Experimental | Patients who received compressive elastic dressing as a hemostasis technique after coronary angiography using radial approach. Receives: Procedure: Compressive Elastic dressing for hemostasis in cardiac procedure using radial approach |
| wristband TR Band | Active comparator | Patients who received wristband TR Band as a hemostasis technique after coronary angiography using radial approach. Receives: Procedure: Wristband TR band for hemostasis in cardiac procedure using radial approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 240 minutes after placement
Number of patient with Hematoma and Grade of hematoma
It is defined by EASY hematoma scale.
Measured: Within 24 hours after the procedure
Secondary outcomes (5)
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.
Measured: Within 24 hours after the procedure
Ischemic changes to the hand
It is noted by clinical features of pallor, absence of pulse, pain, cold, paresthesia or paralysis.
Measured: Within 24 hours after the procedure
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.
Measured: Within 24 hours after the procedure
Number of patient with Radial Artery Occlusion on follow up
Radial artery patency was checked by evaluating radial pulse and Doppler Ultrasonography.
Measured: After 4 weeks of the procedure.
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.
Measured: Within 24 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start1 Aug 2020
- Primary completion1 Jan 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- An-Najah National University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunis Daralammouri, An-Najah National University
- Investigators
- Yunis A Daralammouri, Principal investigator, An-Najah National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05409716
- Sponsor's protocol ID
- TR-Band Vs Gauze Swab
- Acronym
- Band Vs Gauze
- Status last verified
- Sep 2022
- First submitted
- 4 Jun 2022
- Last updated
- 29 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Compressive Elastic Dressing and Hemostatic TR Band Following Cardiac Intervention Utilizing the Radial Technique: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05409716
- Acronym / sponsor ID
- Band Vs Gauze / TR-Band Vs Gauze Swab
- Conditions
- Coronary Artery Disease, Myocardial Infarction, Angina, Unstable, Angina, Stable, Acute Coronary Syndrome, STEMI
- Keywords
- Radial approach, Wristband, TR Band, compressive dressing, cardiac catheterization, radial artery, safeguard, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- An-Najah National UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Compressive Elastic dressing | Experimental | Procedure: Compressive Elastic dressing for hemostasis in cardiac procedure using radial approachPatients who received compressive elastic dressing as a hemostasis technique after coronary angiography using radial approach. |
| wristband TR Band | Active comparator | Procedure: Wristband TR band for hemostasis in cardiac procedure using radial approachPatients who received wristband TR Band as a hemostasis technique after coronary angiography using radial approach. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compressive Elastic dressing for hemostasis in cardiac procedure using radial approachFollowing 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. | Procedure or surgery | Compressive Elastic dressing |
| Wristband TR band for hemostasis in cardiac procedure using radial approachFollowing cardiac procedure using radial approach, hemostatic wristband TR BandR (Terumo Corporation, Tokyo, Japan) was utilized was used to achieve hemostasis. | Procedure or surgery | wristband TR Band |
Primary outcome
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.
Number of patient with Hematoma and Grade of hematoma
Time frame: Within 24 hours after the procedure
It is defined by EASY hematoma scale.
5 secondary outcomes
Number of patient with Radial artery occlusion
Time frame: Within 24 hours after the procedure
Ischemic changes to the hand
Time frame: Within 24 hours after the procedure
Post-procedural pain
Time frame: Within 24 hours after the procedure
Number of patient with Radial Artery Occlusion on follow up
Time frame: After 4 weeks of the procedure.
Patient satisfaction of the used compression methode Assessed by Likert scale for satisfaction
Time frame: Within 24 hrs
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yunis A Daralammouri principal investigator
An-Najah National University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Compressive Elastic dressing for hemostasis in cardiac procedure using radial approach and Wristband TR band for hemostasis in cardiac procedure using radial approach in people with Coronary Artery Disease and Myocardial Infarction, run by An-Najah National University at 2 sites in Palestinian Territories.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Palestinian Territories. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compression "hemostasis" time (time frame: Up to 240 minutes after placement). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2022.