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Assessment of Radial Artery Complications Whilst Achieving Rapid Haemostasis
Assessment of Radial Artery Complications Whilst Achieving Rapid Haemostasis

NCT04457219

TerminatedNA

Sponsor: Liverpool Heart and Chest Hospital NHS Foundation Trust

Conditions: Injury; Blood Vessel, Wrist, Radial Artery

Interventions: Haemostatic Dressing, Conventional Dressing, 120 Minutes External Compression, 60 Minutes External Compression

Countries: United Kingdom

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.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (1)
  • Liverpool, Merseyside, United Kingdom