- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04457219
Assessment of Radial Artery Complications Whilst Achieving Rapid Haemostasis (ARCH)
A Randomised Controlled Trial to Compare Conventional and Haemostatic Dressings to Achieve Rapid and Effective Haemostasis Following Radial Artery Access
Study Overview
Status
Conditions
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:
- Conventional absorbent - an absorbent sterile adhesive dressing. This is our current, standard care.
- 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Merseyside
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Liverpool, Merseyside, United Kingdom, L14 3PE
- Liverpool Heart & Chest Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Conventional dressing with 120 minutes external compression
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.
|
A Conventional Absorbent Dressing is applied at the radial access site, following the transradial angiographic procedure.
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.
|
Experimental: Conventional dressing with 60 minutes external compression
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.
|
A Conventional Absorbent Dressing is applied at the radial access site, following the transradial angiographic procedure.
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.
|
Experimental: Haemostatic dressing with 60 minutes external compression
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.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The rate of failure to achieve haemostasis at the planned compression time
Time Frame: Estimated average of 90 minutes
|
After radial sheath is removed and initial haemostasis is secured by Cath Lab team, new overt bleeding or puncture-related haematoma development, occurring out of the Cath Lab, during planned compression period such that:
OR At the time of planned compression device removal, perceived failure of puncture site haemostasis, manifest as overt bleeding or puncture-related haematoma, that requires re-application of compression (either with the original device, a new device, an additional device, manual compression or a pressure dressing) |
Estimated average of 90 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of bleeding complications
Time Frame: From randomisation until discharge from hospital, estimated average of 8 hours
|
Incidence of bleeding complications related to the arterial puncture. The bleeding complications that will count as secondary outcome measure for the trial will be:
|
From randomisation until discharge from hospital, estimated average of 8 hours
|
Incidence of post-procedural radial artery occlusion
Time Frame: From randomisation until discharge from hospital, estimated average of 8 hours
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Incidence of radial artery occlusion, as a series of parallel, paired comparisons, between the randomised arms of the trial
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From randomisation until discharge from hospital, estimated average of 8 hours
|
Time to Haemostasis
Time Frame: From randomisation until discharge from hospital, estimated average of 8 hours
|
Time to haemostasis is the interval of time between initial haemostasis following sheath removal and all compression removed, without any compromise in final haemostasis.
This outcome measure will report the 'reality' of the time to haemostasis rather than the target period.
|
From randomisation until discharge from hospital, estimated average of 8 hours
|
Incidence of patients with delayed discharge due to the need for radial access site care
Time Frame: Estimated average 12 hours
|
The number and proportion of patients experiencing delayed discharge for reasons related to haemostasis.
An analysis plan, including detail of cost-effectiveness model surrounding this outcome, will be produced at a later stage.
|
Estimated average 12 hours
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Rodney H Stables, Prof, Liverpool Heart & Chest Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 271746
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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