Injury; Blood Vessel, Wrist, Radial ArteryARCHNCT04457219
Assessment of Radial Artery Complications Whilst Achieving Rapid Haemostasis
A study testing Haemostatic Dressing, Conventional Dressing and 120 Minutes External Compression in people with Injury; Blood Vessel, Wrist, Radial Artery, run by Liverpool Heart and Chest Hospital NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Injury; Blood Vessel, Wrist, Radial Artery
- What is being tested?
- Haemostatic Dressing, Conventional Dressing and 120 Minutes External Compression
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,114 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 Jun 2020to 28 Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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 locations and contacts
1 site in 1 country.
United Kingdom1 site
Liverpool Heart & Chest Hospital
Liverpool, Merseyside, L14 3PE
About this study
Official title: A Randomised Controlled Trial to Compare Conventional and Haemostatic Dressings to Achieve Rapid and Effective Haemostasis Following Radial Artery Access
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.
Read the 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.
- Being tested
- Haemostatic Dressing, Conventional Dressing, 120 Minutes External Compression, 60 Minutes External Compression
- Keywords
- Rapid, Haemostasis, Hemostasis, Haemostatic, Hemostatic, Statseal, Radial, Comparative Effectiveness Trial, Pragmatic Design, Low-interventional Trial, Transradial, Percutaneous coronary intervention, Coronary angiography
- Medical subject headings
- Wounds and Injuries, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haemostatic DressingDevice
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.
Conventional DressingDevice
A Conventional Absorbent Dressing is applied at the radial access site, following the transradial angiographic procedure.
120 Minutes External CompressionDevice
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.
60 Minutes External CompressionDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Conventional dressing with 120 minutes external compression | Active comparator | 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. Receives: Device: Conventional Dressing; Device: 120 Minutes External Compression |
| Conventional dressing with 60 minutes external compression | Experimental | 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. Receives: Device: Conventional Dressing; Device: 60 Minutes External Compression |
| Haemostatic dressing with 60 minutes external compression | Experimental | 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. Receives: Device: Haemostatic Dressing; Device: 60 Minutes External Compression |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of failure to achieve haemostasis at the planned compression time
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:
- an additional compression device or pressure dressing is applied OR
- the radial dressing and compression device (either original device or new device) are re-applied de novo OR
- planned compression duration period to be restarted
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)
Measured: Estimated average of 90 minutes
Secondary outcomes (4)
Rate of bleeding complications
Incidence of bleeding complications related to the arterial puncture. The bleeding complications that will count as secondary outcome measure for the trial will be:
- Puncture-related haematoma (grades II, III and IV)
- Vascular surgical or percutaneous intervention for arterial injury or bleeding
Measured: From randomisation until discharge from hospital, estimated average of 8 hours
Incidence of post-procedural radial artery occlusion
Incidence of radial artery occlusion, as a series of parallel, paired comparisons, between the randomised arms of the trial
Measured: From randomisation until discharge from hospital, estimated average of 8 hours
Time to Haemostasis
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.
Measured: 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
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.
Measured: Estimated average 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start18 Jun 2020
- Primary completion28 Jan 2022
- Study completion28 Jan 2022
Why it stopped: Pre-specified interim analysis on data from 2,000 patients by an independent DMSC: recruitment to be stopped early for overwhelming superiority of one of the 3 randomised treatment arms, in the absence of any safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Injury; Blood Vessel, Wrist, Radial ArteryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 3 arms of randomisation (1:1:1 ratio), parallel treatments
- Masking
- None (open label)
- Enrolment
- 2,114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool Heart and Chest Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Biolife LLC, The Johnson Foundation, United Kingdom
- Responsible party
- Sponsor
- Investigators
- Rodney H Stables, Prof, Study director, Liverpool Heart & Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457219
- Sponsor's protocol ID
- 271746
- Acronym
- ARCH
- Status last verified
- Apr 2022
- First submitted
- 15 Jun 2020
- Last updated
- 14 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial to Compare Conventional and Haemostatic Dressings to Achieve Rapid and Effective Haemostasis Following Radial Artery Access
- ClinicalTrials.gov ID
- NCT04457219
- Acronym / sponsor ID
- ARCH / 271746
- Keywords
- Rapid, Haemostasis, Hemostasis, Haemostatic, Hemostatic, Statseal, Radial, Comparative Effectiveness Trial
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Pre-specified interim analysis on data from 2,000 patients by an independent DMSC: recruitment to be stopped early for overwhelming superiority of one of the 3 randomised treatment arms, in the absence of any safety concerns.
- Enrolment
- 2,114 participants (actual)
- Lead sponsor
- Liverpool Heart and Chest Hospital NHS Foundation TrustUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, Biolife LLC, The Johnson Foundation, United Kingdom
- Study start
- 18 Jun 2020 (actual)
- Primary completion
- 28 Jan 2022 (actual)
- Study completion
- 28 Jan 2022 (actual)
- First posted
- 7 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 3 arms of randomisation (1:1:1 ratio), parallel treatments
| Arm | Type | Receives |
|---|---|---|
| Conventional dressing with 120 minutes external compression | Active comparator | Device: Conventional Dressing, Device: 120 Minutes External CompressionA 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. |
| Conventional dressing with 60 minutes external compression | Experimental | Device: Conventional Dressing, Device: 60 Minutes External CompressionA 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. |
| Haemostatic dressing with 60 minutes external compression | Experimental | Device: Haemostatic Dressing, Device: 60 Minutes External CompressionA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Haemostatic DressingA 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 | Haemostatic dressing with 60 minutes external compression |
| Conventional DressingA Conventional Absorbent Dressing is applied at the radial access site, following the transradial angiographic procedure. | Device | Conventional dressing with 120 minutes external compression, Conventional dressing with 60 minutes external compression |
| 120 Minutes External CompressionA 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 | Conventional dressing with 120 minutes external compression |
| 60 Minutes External CompressionA 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. | Device | Conventional dressing with 60 minutes external compression, Haemostatic dressing with 60 minutes external compression |
Primary outcome
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: * an additional compression device or pressure dressing is applied OR * the radial dressing and compression device (either original device or new device) are re-applied de novo OR * planned compression duration period to be restarted 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)
4 secondary outcomes
Rate of bleeding complications
Time frame: 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
Time to Haemostasis
Time frame: 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
Results and safety
The study was stopped early (reason given: Pre-specified interim analysis on data from 2,000 patients by an independent DMSC: recruitment to be stopped early for overwhelming superiority of one of the 3 randomised treatment arms, in the absence of any safety concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2022.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodney H Stables, Prof study director
Liverpool Heart & Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Haemostatic Dressing, Conventional Dressing and 120 Minutes External Compression in people with Injury; Blood Vessel, Wrist, Radial Artery, run by Liverpool Heart and Chest Hospital NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Pre-specified interim analysis on data from 2,000 patients by an independent DMSC: recruitment to be stopped early for overwhelming superiority of one of the 3 randomised treatment arms, in the absence of any safety concerns.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of failure to achieve haemostasis at the planned compression time (time frame: Estimated average of 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.