Two HEmostasis Methods After TransradIal Catheterization: THEMATIC - protocol for a randomized clinical trial

Area of Science:

• Cardiovascular Interventions
• Vascular Access
• Medical Device Technology

Background:

• Transradial procedures are increasingly common for percutaneous cardiovascular interventions.
• Radial artery occlusion (RAO) is a potential complication following these procedures.
• Effective hemostasis is crucial to minimize RAO and ensure future vascular access.

Purpose of the Study:

• To evaluate the incidence of radial artery occlusion using two distinct arterial compression devices.
• To compare the efficacy and safety of the TR Band™ device versus conventional elastic adhesive bandages for hemostasis.
• To provide evidence-based recommendations for post-transradial procedure hemostasis.

Main Methods:

• A randomized clinical trial protocol involving adult patients undergoing transradial procedures.
• Patients with specific plethysmographic patterns (A, B, or C) will be included.
• Random assignment (1:1) to either TR Band™ device or conventional elastic bandage for hemostasis.
• Primary outcome: incidence of radial artery occlusion; Secondary outcomes: various safety and efficacy parameters.

Main Results:

• The primary outcome is the incidence of radial artery occlusion.
• Secondary outcomes include Barbeau's test changes, hemostasis time, bleeding, pain, and access-site complications.
• Cost-effectiveness analysis between the two devices will also be conducted.

Conclusions:

• The study aims to offer valuable insights into the most effective hemostasis method after transradial interventions.
• Findings will inform clinical practice regarding the choice of arterial compression devices.
• This research contributes to improving patient outcomes and safety in interventional cardiology.