NCT04457219

Assessment of Radial Artery Complications Whilst Achieving Rapid Haemostasis

A Randomised Controlled Trial to Compare Conventional and Haemostatic Dressings to Achieve Rapid and Effective Haemostasis Following Radial Artery Access

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,114 (actual)
• Sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare different protocols aimed at achieving haemostasis (i.e. stop the bleeding) in patients undergoing heart procedures with access through the wrist. Specifically, a haemostatic dressing that aids clotting at the level of the skin will be used and compared with a normal absorbent dressing. Also, a shorter time of compression required to stop the bleeding at the access site will be evaluated.

Detailed description

Radial access for percutaneous cardiac procedures is the preferred method used by most interventional cardiologists. This method has proven to have the least complications and a much quicker patient's recovery time, compared to other access sites (e.g. femoral or brachial). Following sheath removal, a dressing is applied on the skin at the access site. Dressing currently in use include: 1. Conventional absorbent - an absorbent sterile adhesive dressing. This is our current, standard care. 2. Haemostatic - a sterile mineral-based absorbent dressing that aids clotting. It is not currently used at Liverpool Heart and Chest Hospital (LHCH), but it is a licenced product. A radial compression device is placed over the dressing, and it applies the appropriate amount of mechanical pressure to guarantee patent haemostasis. This study will recruit patients who are undergoing a cardiac procedure with intended radial access, as part of their standard care. The aim of this study to look at new techniques to reduce the time to successful and complete haemostasis. This may help to expedite patient discharge (avoiding unplanned overnight stay), to reduce nursing times and to decrease the rate of post-procedural, access site-related bleeding and ischemic complications. At the end of the cardiac procedure, participants will be randomised in a 1:1:1 ratio to one of the following 3 arms: Arm 1 - conventional absorbent dressing and a compression device applied for 60 mins; Arm 2 - conventional absorbent dressing with a compression device applied for 120 mins (the current standard practice at LHCH); Arm 3 - haemostatic dressing and a compression device applied for 60 mins. This is a low-interventional, low-risk, pragmatic study comparing strategies that are currently used in every-day clinical practice. The consent seeking process is proportionate and adapted to the design of the study. Data collection will be electronic and will be performed by medical and nursing staff as part of their normal clinical practice. This will obviate the use of paper-based case record forms. This study will actively involve medical and nursing staff across the hospital, facilitating multidisciplinary collaboration and integration of clinical research with everyday clinical practice.

Conditions

• Injury; Blood Vessel, Wrist, Radial Artery

Interventions

Type	Name	Description
DEVICE	Haemostatic Dressing	A Hemostatic Dressing is applied at the radial access site, following a transradial angiographic procedure. This is a mineral-based dressing with a hydrophilic polymer that works independently of the clotting cascade to seal the site, by accelerating topical hemostasis.
DEVICE	Conventional Dressing	A Conventional Absorbent Dressing is applied at the radial access site, following the transradial angiographic procedure.
DEVICE	120 Minutes External Compression	A radial compression device is applied at the radial access site to achieve patent hemostasis. The device remains in situ for 2 hours. Prolonged time of compression may be required.
DEVICE	60 Minutes External Compression	A radial compression device is applied at the radial access site to achieve patent hemostasis. The device remains in situ for 1 hour. Prolonged time of compression may be required.

Timeline

• Start date: 2020-06-18
• Primary completion: 2022-01-28
• Completion: 2022-01-28
• First posted: 2020-07-07
• Last updated: 2022-04-14

Locations

1 site across 1 country: United Kingdom