Injury; Blood Vessel, Wrist, Radial Artery
Conditions
Keywords
Rapid, Haemostasis, Hemostasis, Haemostatic, Hemostatic, Statseal, Radial, Comparative Effectiveness Trial, Pragmatic Design, Low-interventional Trial, Transradial, Percutaneous coronary intervention, Coronary angiography
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.
Interventions
DEVICEHaemostatic 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.
DEVICEConventional Dressing
A Conventional Absorbent Dressing is applied at the radial access site, following the transradial angiographic procedure.
DEVICE120 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.
DEVICE60 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.
Sponsors
National Institute for Health Research, United Kingdom
Biolife LLC
The Johnson Foundation, United Kingdom
Liverpool Heart and Chest Hospital NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
3 arms of randomisation (1:1:1 ratio), parallel treatments
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of failure to achieve haemostasis at the planned compression time | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of bleeding complications | 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: * Puncture-related haematoma (grades II, III and IV) * Vascular surgical or percutaneous intervention for arterial injury or bleeding |
| Incidence of post-procedural radial artery occlusion | From randomisation until discharge from hospital, estimated average of 8 hours | Incidence of radial artery occlusion, as a series of parallel, paired comparisons, between the randomised arms of the trial |
| Time to Haemostasis | 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. |
| Incidence of patients with delayed discharge due to the need for radial access site care | 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. |
Countries
United Kingdom
Outcome results
None listed