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Assessment of Radial Artery Complications Whilst Achieving Rapid Haemostasis

NCT04457219 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2114

Last updated 2022-04-14

No results posted yet for this study

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

Interventions

DEVICE

Haemostatic Dressing

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.

DEVICE

Conventional Dressing

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

DEVICE

120 Minutes External Compression

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.

DEVICE

60 Minutes External Compression

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.

Sponsors & Collaborators

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • Biolife LLC

    collaborator UNKNOWN

  • The Johnson Foundation, United Kingdom

    collaborator UNKNOWN

  • Liverpool Heart and Chest Hospital NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Rodney H Stables, Prof · Liverpool Heart & Chest Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-18
Primary Completion
2022-01-28
Completion
2022-01-28

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04457219 on ClinicalTrials.gov