TR Band Combined With Adrenaline Drops Versus TR Band Alone for Radial Artery Hemostasis After Cardiac Catheterization

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.

• Transradial band with adrenaline drops (Drug): 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 alone (Device): 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.

Primary outcomes

• Time to complete TR Band deflation [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.

Secondary outcomes

• radial artery occlusion [Before hospital discharge or at the scheduled post-procedural assessment]: The occurrence of radial artery occlusion at the radial access site after cardiac catheterization, assessed by clinical examination using reverse Barbeau test
• Radial access-site hematoma [From completion of TR Band removal until 24 hours after TR Band removal.]: 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.

Sex: All, ages: 18 Years to 100 Years

Inclusion Criteria:

Patients over 18 years of age who scheduled for coronary angiography or percutaneous coronary intervention

Exclusion Criteria:

* 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
* History of RAO at base line
* Had developed vascular complications from the procedure
* Failed to establish radial access

• 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. PMID 35450681
• Results publication: Seto 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. PMID 29769165