Status:
TERMINATED
Assessment of Radial Artery Complications Whilst Achieving Rapid Haemostasis
Lead Sponsor:
Liverpool Heart and Chest Hospital NHS Foundation Trust
Collaborating Sponsors:
National Institute for Health Research, United Kingdom
Biolife LLC
Conditions:
Injury; Blood Vessel, Wrist, Radial Artery
Eligibility:
All Genders
18+ years
Phase:
NA
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,...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
June 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2022
Estimated Enrollment :
2114 Patients enrolled
Trial Details
Trial ID
NCT04457219
Start Date
June 18 2020
End Date
January 28 2022
Last Update
April 14 2022
Active Locations (1)
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1
Liverpool Heart & Chest Hospital
Liverpool, Merseyside, United Kingdom, L14 3PE