TerminatedNot Applicable

Assessment of Radial Artery Complications Whilst Achieving Rapid Haemostasis

Stopped: Pre-specified interim analysis on data from 2,000 patients by an independent DMSC: recruitment to be stopped early for overwhelming superiority of one of the 3 randomised treatment arms, in the absence of any safety concerns.

United Kingdom2,114 participantsStarted 2020-06-18

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The rate of failure to achieve haemostasis at the planned compression time

Timeframe: Estimated average of 90 minutes

Trial details

NCT IDNCT04457219

SponsorLiverpool Heart and Chest Hospital NHS Foundation Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-01-28

View on ClinicalTrials.gov More Injury; Blood Vessel, Wrist, Radial Artery trials