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Search / Trial NCT04457219

Assessment of Radial Artery Complications Whilst Achieving Rapid Haemostasis

Launched by LIVERPOOL HEART AND CHEST HOSPITAL NHS FOUNDATION TRUST · Jun 30, 2020

Trial Information

Current as of July 02, 2025

Terminated

Keywords

Rapid Haemostasis Hemostasis Haemostatic Hemostatic Statseal Radial Comparative Effectiveness Trial Pragmatic Design Low Interventional Trial Transradial Percutaneous Coronary Intervention Coronary Angiography

ClinConnect Summary

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 us...

Gender

ALL

Eligibility 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 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

About Liverpool Heart And Chest Hospital Nhs Foundation Trust

Liverpool Heart and Chest Hospital NHS Foundation Trust is a leading healthcare institution in the UK, specializing in cardiothoracic care and research. Renowned for its commitment to clinical excellence and innovative practices, the Trust plays a pivotal role in advancing medical knowledge through rigorous clinical trials. With a multidisciplinary team of experts, it focuses on developing and evaluating new treatments and interventions for heart and lung conditions, ensuring high standards of patient safety and care. The Trust's dedication to enhancing patient outcomes and contributing to the field of cardiology and thoracic medicine positions it as a key player in the NHS's research landscape.

Locations

Liverpool, Merseyside, United Kingdom

Patients applied

0 patients applied

Trial Officials

Rodney H Stables, Prof

Study Director

Liverpool Heart & Chest Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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