Assessment of Radial Artery Complications Whilst Achieving Rapid Haemostasis

NCT04457219 | Terminated DMC

• 1 other identifier: 271746
• Study Type: interventional
• Target: 2,114
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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)

  Estimated average of 90 minutes

Secondary Outcomes (4)

• Rate of bleeding complications

  From randomisation until discharge from hospital, estimated average of 8 hours

• Incidence of post-procedural radial artery occlusion

  From randomisation until discharge from hospital, estimated average of 8 hours

• Time to Haemostasis

  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

  Estimated average 12 hours

Study Arms (3)

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.

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.

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.

Device: Haemostatic Dressing; Device: 60 Minutes External Compression

Interventions

Haemostatic Dressing DEVICE

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.

Haemostatic dressing with 60 minutes external compression

Conventional Dressing DEVICE

A Conventional Absorbent Dressing is applied at the radial access site, following the transradial angiographic procedure.

Conventional dressing with 120 minutes external compression; Conventional dressing with 60 minutes external compression

120 Minutes External Compression DEVICE

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.

Conventional dressing with 120 minutes external compression

60 Minutes External Compression DEVICE

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.

Conventional dressing with 60 minutes external compression; Haemostatic dressing with 60 minutes external compression

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• \< 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
• Single radial sheath in situ with planned removal in lab
• 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

Sponsors & Collaborators

• Liverpool Heart and Chest Hospital NHS Foundation Trust: lead
• National Institute for Health Research, United Kingdom: collaborator
• Biolife LLC: collaborator
• The Johnson Foundation, United Kingdom: collaborator

Study Sites (1)

Liverpool Heart & Chest Hospital

Liverpool, Merseyside, L14 3PE, United Kingdom

Location

MeSH Terms

Conditions

Wounds and Injuries; Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Rodney H Stables, Prof

  Liverpool Heart & Chest Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 3 arms of randomisation (1:1:1 ratio), parallel treatments

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: July 7, 2020
• Study Start: June 18, 2020
• Primary Completion: January 28, 2022
• Study Completion: January 28, 2022
• Last Updated: April 14, 2022

Record last verified: 2022-04

Locations

GB (1)