Radial Artery HemostasisNCT07877922
TR Band Combined With Adrenaline Drops Versus TR Band Alone for Radial Artery Hemostasis After Cardiac Catheterization
A study testing Transradial band with adrenaline drops and Transradial band alone in people with Radial Artery Hemostasis, run by Burapha University at 1 site in Thailand.
Trial summary
This randomized controlled trial aims to compare the effectiveness and safety of a transradial band combined with adrenaline drops versus a transradial band alone for achieving radial artery hemostasis after cardiac catheterization. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Radial Artery Hemostasis
- What is being tested?
- Transradial band with adrenaline drops and Transradial band alone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteThailand
- Study dates
- 15 Oct 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients over 18 years of age who scheduled for coronary angiography or percutaneous coronary intervention
Who cannot join
- Patients with sheath larger than 6-F in diameter
- long-term oral anticoagulation continued during the procedure
- Ipsilateral arteriovenous fistula
- Clinical instability
- Barbeau class D on radial plethysmography
- Known vascular disease or deformity of the forearm
Show all 9Show fewer
- History of RAO at base line
- Had developed vascular complications from the procedure
- Failed to establish radial access
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site
Burapha University Hospital
Chon Buri, 20131
Sukrisd Koowattanatianchai, Doctor, +66816633007, sukrisd.ko@go.buu.ac.th
About this study
Official title: Transradial Band Combined With Adrenaline Drops Versus Transradial Band Alone for Radial Artery Hemostasis After Cardiac Catheterization: Randomized Controlled Trial
This randomized controlled trial aims to compare the effectiveness and safety of a transradial band combined with adrenaline drops versus a transradial band alone for achieving radial artery hemostasis after cardiac catheterization. Adult patients undergoing diagnostic coronary angiography or percutaneous coronary intervention through the radial artery will be randomly assigned to one of the two treatment groups. The primary objective is to determine whether the addition of adrenaline drops reduces the time required for complete transradial band deflation while maintaining effective hemostasis. Secondary outcomes include radial artery occlusion and hematoma formation. The study hypothesis is that the combination of a transradial band and adrenaline drops will shorten hemostasis time without increasing complications compared with the standard transradial band alone.
Read the detailed description
Transradial access has become the preferred vascular access route for diagnostic coronary angiography and percutaneous coronary intervention because it is associated with lower rates of bleeding and vascular complications, earlier patient ambulation, improved patient comfort, and reduced healthcare costs compared with transfemoral access. However, achieving effective hemostasis after radial artery sheath removal remains an important aspect of post-procedural care. Excessive compression may increase the risk of radial artery occlusion, whereas inadequate compression may lead to bleeding and hematoma formation.
The TR Band is widely used for radial artery hemostasis following transradial cardiac catheterization. Adrenaline possesses local vasoconstrictive properties and may enhance hemostasis at the puncture site, potentially reducing the duration of compression required to achieve complete hemostasis. However, evidence regarding the adjunctive use of topical adrenaline with TR Band compression after transradial cardiac catheterization is limited.
This study is a prospective, single-center, randomized controlled trial conducted at Burapha University Hospital, Thailand. Adult patients undergoing diagnostic coronary angiography or percutaneous coronary intervention through transradial access will be randomly assigned in a 1:1 ratio to receive either:
Transradial Band combined with adrenaline drops (intervention group) Transradial Band alone (control group)
After completion of the cardiac catheterization procedure and sheath removal, hemostasis will be achieved according to the study protocol. In the intervention group, adrenaline drops will be applied at the radial artery puncture site before TR Band compression. In the control group, standard TR Band compression alone will be used.
The primary objective is to determine whether the addition of adrenaline drops reduces the time required for complete TR Band deflation while maintaining effective hemostasis. Secondary objectives include evaluation of radial artery occlusion and hematoma formation.
The investigators hypothesize that the combination of a Transradial Band and adrenaline drops will shorten the duration of radial compression and facilitate earlier hemostasis without increasing vascular complications compared with standard Transradial Band compression alone.
The findings of this study may provide evidence for a simple, inexpensive, and easily applicable strategy to improve post-procedural management after transradial cardiac catheterization.
- Conditions
- Radial Artery Hemostasis
- Being tested
- Transradial band with adrenaline drops, Transradial band alone
- Keywords
- cardiac catherization, transradial band, Adrenaline drops
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transradial band with adrenaline dropsDrug
Participants randomized to this intervention arm will receive adrenaline drops applied to the radial artery puncture site followed by application of a Transradial Band for radial artery hemostasis after removal of the radial artery sheath. The Transradial Band will be managed according to the study protocol, with gradual deflation until complete deflation is achieved without bleeding or oozing
Transradial band aloneDevice
Participants randomized to this control arm will receive a Transradial Band alone for radial artery hemostasis after removal of the radial artery sheath. The Transradial Band will be managed according to the study protocol, with gradual deflation until complete deflation is achieved without bleeding or oozing.
| Study group | Role | What they receive |
|---|---|---|
| Transradial band alone | Active comparator | Participants randomized to this control arm will receive a Transradial Band alone for radial artery hemostasis after removal of the radial artery sheath. The Transradial Band will be managed according to the study protocol, with gradual deflation until complete deflation is achieved without bleeding or oozing. Receives: Device: Transradial band alone |
| Transradial band with adrenaline drops | Experimental | Participants randomized to this intervention arm will receive adrenaline drops applied to the radial artery puncture site followed by application of a Transradial Band for radial artery hemostasis after removal of the radial artery sheath. The Transradial Band will be managed according to the study protocol, with gradual deflation until complete deflation is achieved without bleeding or oozing Receives: Drug: Transradial band with adrenaline drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to complete TR Band deflation
Time from initiation of TR Band deflation to complete removal of all air from the TR Band without bleeding or oozing from the radial artery access site.
Measured: From initiation of TR Band deflation until complete removal of all air from the TR Band without bleeding or oozing, assessed up to 300 minutes.
Secondary outcomes (2)
radial artery occlusion
The occurrence of radial artery occlusion at the radial access site after cardiac catheterization, assessed by clinical examination using reverse Barbeau test
Measured: Before hospital discharge or at the scheduled post-procedural assessment
Radial access-site hematoma
The occurrence and severity of hematoma at the radial artery access site after cardiac catheterization, assessed after TR Band removal according to the study protocol.
Measured: From completion of TR Band removal until 24 hours after TR Band removal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start15 Oct 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Radial Artery HemostasisStudies 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
- Model description
- This is a prospective, single-center, two-arm, parallel-group randomized controlled trial. Eligible participants undergoing diagnostic coronary angiography or percutaneous coronary intervention through transradial access will be randomly assigned in a 1:1 ratio to receive either a Transradial Band combined with adrenaline drops or a Transradial Band alone for radial artery hemostasis after cardiac catheterization.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Burapha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sukrisd Koowattanatianchai, Burapha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877922
- Sponsor's protocol ID
- HS 123/2568
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly because the study involves a relatively small number of participants, and sharing individual-level data may present a risk of participant re-identification. The data are also subject to institutional and ethical requirements regarding participant confidentiality. De-identified data may be considered for sharing upon reasonable request, subject to approval by the appropriate institutional review board and compliance with applicable data protection requirements.
Publications
Safirstein JG, Tehrani DM, Schussler JM, Reid N, Mukerjee K, Weber L, Liu H, Skenderian S, Simeon M, Yang T, Seto AH. Radial Hemostasis Is Facilitated With a Potassium Ferrate Hemostatic Patch: The STAT2 Trial. JACC Cardiovasc Interv. 2022 Apr 25;15(8):810-819. doi: 10.1016/j.jcin.2021.12.030.
PubMed 35450681Seto AH, Rollefson W, Patel MP, Suh WM, Tehrani DM, Nguyen JA, Amador DG, Behnamfar O, Garg V, Cohen MG. Radial haemostasis is facilitated with a potassium ferrate haemostatic patch: the Statseal with TR Band assessment trial (STAT). EuroIntervention. 2018 Dec 7;14(11):e1236-e1242. doi: 10.4244/EIJ-D-18-00101.
PubMed 29769165
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transradial Band Combined With Adrenaline Drops Versus Transradial Band Alone for Radial Artery Hemostasis After Cardiac Catheterization: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07877922
- Acronym / sponsor ID
- HS 123/2568
- Conditions
- Radial Artery Hemostasis
- Keywords
- cardiac catherization, transradial band, Adrenaline drops
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Burapha UniversityUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 16 Oct 2026 (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.
This randomized controlled trial aims to compare the effectiveness and safety of a transradial band combined with adrenaline drops versus a transradial band alone for achieving radial artery hemostasis after cardiac catheterization. Adult patients undergoing diagnostic coronary angiography or percutaneous coronary intervention through the radial artery will be randomly assigned to one of the two treatment groups. The primary objective is to determine whether the addition of adrenaline drops reduces the time required for complete transradial band deflation while maintaining effective hemostasis. Secondary outcomes include radial artery occlusion and hematoma formation. The study hypothesis is that the combination of a transradial band and adrenaline drops will shorten hemostasis time without increasing complications compared with the standard transradial band alone.
Detailed description
Transradial access has become the preferred vascular access route for diagnostic coronary angiography and percutaneous coronary intervention because it is associated with lower rates of bleeding and vascular complications, earlier patient ambulation, improved patient comfort, and reduced healthcare costs compared with transfemoral access. However, achieving effective hemostasis after radial artery sheath removal remains an important aspect of post-procedural care. Excessive compression may increase the risk of radial artery occlusion, whereas inadequate compression may lead to bleeding and hematoma formation.
The TR Band is widely used for radial artery hemostasis following transradial cardiac catheterization. Adrenaline possesses local vasoconstrictive properties and may enhance hemostasis at the puncture site, potentially reducing the duration of compression required to achieve complete hemostasis. However, evidence regarding the adjunctive use of topical adrenaline with TR Band compression after transradial cardiac catheterization is limited.
This study is a prospective, single-center, randomized controlled trial conducted at Burapha University Hospital, Thailand. Adult patients undergoing diagnostic coronary angiography or percutaneous coronary intervention through transradial access will be randomly assigned in a 1:1 ratio to receive either:
Transradial Band combined with adrenaline drops (intervention group) Transradial Band alone (control group)
After completion of the cardiac catheterization procedure and sheath removal, hemostasis will be achieved according to the study protocol. In the intervention group, adrenaline drops will be applied at the radial artery puncture site before TR Band compression. In the control group, standard TR Band compression alone will be used.
The primary objective is to determine whether the addition of adrenaline drops reduces the time required for complete TR Band deflation while maintaining effective hemostasis. Secondary objectives include evaluation of radial artery occlusion and hematoma formation.
The investigators hypothesize that the combination of a Transradial Band and adrenaline drops will shorten the duration of radial compression and facilitate earlier hemostasis without increasing vascular complications compared with standard Transradial Band compression alone.
The findings of this study may provide evidence for a simple, inexpensive, and easily applicable strategy to improve post-procedural management after transradial cardiac catheterization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This is a prospective, single-center, two-arm, parallel-group randomized controlled trial. Eligible participants undergoing diagnostic coronary angiography or percutaneous coronary intervention through transradial access will be randomly assigned in a 1:1 ratio to receive either a Transradial Band combined with adrenaline drops or a Transradial Band alone for radial artery hemostasis after cardiac catheterization.
| Arm | Type | Receives |
|---|---|---|
| Transradial band alone | Active comparator | Device: Transradial band aloneParticipants randomized to this control arm will receive a Transradial Band alone for radial artery hemostasis after removal of the radial artery sheath. The Transradial Band will be managed according to the study protocol, with gradual deflation until complete deflation is achieved without bleeding or oozing. |
| Transradial band with adrenaline drops | Experimental | Drug: Transradial band with adrenaline dropsParticipants randomized to this intervention arm will receive adrenaline drops applied to the radial artery puncture site followed by application of a Transradial Band for radial artery hemostasis after removal of the radial artery sheath. The Transradial Band will be managed according to the study protocol, with gradual deflation until complete deflation is achieved without bleeding or oozing |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 18 years of age who scheduled for coronary angiography or percutaneous coronary intervention
Key exclusion criteria (9 listed)
- Patients with sheath larger than 6-F in diameter
- long-term oral anticoagulation continued during the procedure
- Ipsilateral arteriovenous fistula
- Clinical instability
- Barbeau class D on radial plethysmography
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 |
|---|---|---|
| Transradial band with adrenaline dropsParticipants randomized to this intervention arm will receive adrenaline drops applied to the radial artery puncture site followed by application of a Transradial Band for radial artery hemostasis after removal of the radial artery sheath. The Transradial Band will be managed according to the study protocol, with gradual deflation until complete deflation is achieved without bleeding or oozing | Drug | Transradial band with adrenaline drops |
| Transradial band aloneParticipants randomized to this control arm will receive a Transradial Band alone for radial artery hemostasis after removal of the radial artery sheath. The Transradial Band will be managed according to the study protocol, with gradual deflation until complete deflation is achieved without bleeding or oozing. | Device | Transradial band alone |
Primary outcome
Time to complete TR Band deflation
Time frame: From initiation of TR Band deflation until complete removal of all air from the TR Band without bleeding or oozing, assessed up to 300 minutes.
Time from initiation of TR Band deflation to complete removal of all air from the TR Band without bleeding or oozing from the radial artery access site.
2 secondary outcomes
radial artery occlusion
Time frame: Before hospital discharge or at the scheduled post-procedural assessment
Radial access-site hematoma
Time frame: From completion of TR Band removal until 24 hours after TR Band removal.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Background: PubMed 35450681Safirstein JG, Tehrani DM, Schussler JM, Reid N, Mukerjee K, Weber L, Liu H, Skenderian S, Simeon M, Yang T, Seto AH. Radial Hemostasis Is Facilitated With a Potassium Ferrate Hemostatic Patch: The STAT2 Trial. JACC Cardiovasc Interv. 2022 Apr 25;15(8):810-819. doi: 10.1016/j.jcin.2021.12.030.
- Results publication: PubMed 29769165Seto AH, Rollefson W, Patel MP, Suh WM, Tehrani DM, Nguyen JA, Amador DG, Behnamfar O, Garg V, Cohen MG. Radial haemostasis is facilitated with a potassium ferrate haemostatic patch: the Statseal with TR Band assessment trial (STAT). EuroIntervention. 2018 Dec 7;14(11):e1236-e1242. doi: 10.4244/EIJ-D-18-00101.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly because the study involves a relatively small number of participants, and sharing individual-level data may present a risk of participant re-identification. The data are also subject to institutional and ethical requirements regarding participant confidentiality. De-identified data may be considered for sharing upon reasonable request, subject to approval by the appropriate institutional review board and compliance with applicable data protection requirements.
Related trials for Radial Artery Hemostasis
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Potassium Ferrate Hemostatic Sealant-Assisted Early Radial Hemostasis After Transradial Coronary Angiography and PCI
Coronary Angiogram, Early Discharge Trans Radial Angiography
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Flow Dynamics During Simulated Hemostasis at the Proximal and Distal Radial Arteries
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Radial Artery Occlusion
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transradial band with adrenaline drops and Transradial band alone in people with Radial Artery Hemostasis, run by Burapha University at 1 site in Thailand.
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 1 inclusion and 9 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: opening soon, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sukrisd Koowattanatianchai, Doctor (+66816633007, sukrisd.ko@go.buu.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to complete TR Band deflation (time frame: From initiation of TR Band deflation until complete removal of all air from the TR Band without bleeding or oozing, assessed up to 300 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07877922, which also lists 2 linked publications.
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 16 Oct 2026.