Assessment of Radial Artery Complications Whilst Achieving Rapid Haemostasis (ARCH)

Liverpool Heart and Chest Hospital NHS Foundation Trust

Status: Terminated

Conditions: Injury; Blood Vessel, Wrist, Radial Artery

Treatments: Device: 120 Minutes External Compression; Device: Haemostatic Dressing; Device: Conventional Dressing; Device: 60 Minutes External Compression

Study type: Interventional

Funder types: Other

Identifiers

NCT04457219

271746

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,114 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Pre-Cath Lab Inclusion Criterion:

Patients scheduled for angiographic procedure with proposed radial access, regardless of their gender identity, ethnicity and religious belief

Pre-Cath Lab Exclusion Criteria:

• < 18 years of age
• Planned bilateral radial access
• Any haematoma (> 5 cm in its longest dimension) at planned puncture site prior to radial sheath insertion
• Established diagnosis of any haematologic disorder or genetic defect predisposing to bleeding
• Patients with International Normalised Ratio (INR) > 2.5 prior to the scheduled angiographic procedure
• Inability to perform adequate consent: communication issues (e.g. mental capacity); inadequate time for the participant to read and consider trial; unscheduled Urgent or Emergency procedures i.e. PPCI
• Patients who are scheduled to be transferred to other hospitals ("treat and return") before haemostasis is achieved.
• Electronic Patient Record technical failure leading to an inability to record participants' care

In-Cath Lab Inclusion Criterion:

Single radial sheath in situ with planned removal in lab

In-Cath Lab Exclusion Criteria:

• Sheath removal after 17:00 hrs
• Patient leaving lab with radial sheath in situ
• Trans-ulnar procedure
• Distal (snuffbox) trans-radial procedure
• Any puncture-related haematoma (> 5cm in its longest dimension) prior to radial sheath removal
• Randomisation system not available
• Dressings of both types not available
• A change in patient's clinical condition during procedure deemed by the operator sufficient to exclude from the trial
• Procedural complication requiring procedure termination

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,114 participants in 3 patient groups

Conventional dressing with 120 minutes external compression

Active Comparator group

Description:

A standard absorbent dressing is placed on the radial access site, following the transradial angiographic procedure. A radial compression device is then applied to secure patent haemostasis, once the radial sheath is removed. The compression device remains in place for a minimum of 2 hours, as per protocol. This is the standard radial care currently in use at Liverpool Heart and Chest Hospital.

Treatment:

Device: Conventional Dressing

Device: 120 Minutes External Compression

Conventional dressing with 60 minutes external compression

Experimental group

Description:

A standard absorbent dressing is placed on the radial access site, following the transradial angiographic procedure. A radial compression device is then applied to secure patent haemostasis, once the radial sheath is removed. The compression device remains in place for a minimum of 1 hour, as per protocol.

Treatment:

Device: Conventional Dressing

Device: 60 Minutes External Compression

Haemostatic dressing with 60 minutes external compression

Experimental group

Description:

A haemostatic absorbent dressing is placed on the radial access site, following the transradial angiographic procedure. This consists of a mineral-based dressing that accelerates local haemostasis. A radial compression device is then applied to secure patent haemostasis, once the radial sheath is removed. The compression device remains in place for a minimum of 1 hour, as per protocol.

Treatment:

Device: Haemostatic Dressing

Device: 60 Minutes External Compression