An interventional study of Transradial band with adrenaline drops and Transradial band alone in Radial Artery Hemostasis, sponsored by Burapha University. Not yet recruiting at 1 site in Thailand. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Burapha University · Not applicable, Interventional, and Treatment
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.
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.
Burapha University is the lead sponsor of 14 studies on the registry; 3 are open to participants now.
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Patients over 18 years of age who scheduled for coronary angiography or percutaneous coronary intervention
Exclusion Criteria:
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.
Device: Transradial band alone
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
Drug: Transradial band with adrenaline drops
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
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.
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.
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.
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
Time frame: 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.
Time frame: From completion of TR Band removal until 24 hours after TR Band removal.
Plan to share: 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.
Start is estimated for Oct 2026; primary completion for Dec 2026, 2 months later.
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