Clinical trial NCT04457219: Assessment of Radial Artery Complications Whilst Achieving Rapid Haemostasis
Official title: A Randomised Controlled Trial to Compare Conventional and Haemostatic Dressings to Achieve Rapid and Effective Haemostasis Following Radial Artery Access
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Injury; Blood Vessel, Wrist, Radial Artery
Keywords: Rapid
Haemostasis
Hemostasis
Haemostatic
Hemostatic
Statseal
Radial
Comparative Effectiveness Trial
Pragmatic Design
Low-interventional Trial
Transradial
Percutaneous coronary intervention
Coronary angiography
Lead sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
name: Biolife LLC
name: The Johnson Foundation, United Kingdom
First posted: 2020-07-07
Enrollment: 2114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 3 arms of randomisation (1:1:1 ratio), parallel treatments
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: The rate of failure to achieve haemostasis at the planned compression time
timeFrame: Estimated average of 90 minutes
Secondary outcomes:
measure: Rate of bleeding complications
timeFrame: From randomisation until discharge from hospital, estimated average of 8 hours
measure: Incidence of post-procedural radial artery occlusion
timeFrame: From randomisation until discharge from hospital, estimated average of 8 hours
measure: Time to Haemostasis
timeFrame: From randomisation until discharge from hospital, estimated average of 8 hours
measure: Incidence of patients with delayed discharge due to the need for radial access site care
timeFrame: Estimated average 12 hours
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool Heart & Chest Hospital
state: Merseyside
Study officials:
affiliation: Liverpool Heart & Chest Hospital
name: Rodney H Stables, Prof
role: STUDY_DIRECTOR
References: