A study of the Celox Rapid dressing in severely bleeding patients
Research type
Research Study
Full title
Post-market Clinical Study to Evaluate the Clinical Performance and Safety of CELOX™ RAPID Haemostatic Z-Fold Gauze in Civilians with Life Threatening Bleeding Treated in a Pre-Hospital Setting
IRAS ID
282441
Contact name
Steve Bell
Contact email
Sponsor organisation
Medtrade Products Ltd
Clinicaltrials.gov Identifier
TRAU 49710, NIHR CRN reference
Duration of Study in the UK
0 years, 10 months, 0 days
Research summary
Celox Rapid, a haemostatic gauze, is an approved (CE marked) medical device available since 2012. This dressing is used in pre-hospital settings, mainly by ambulance or military personnel, in patients with life threatening emergency bleeding. The dressing is a temporary measure used to control the bleeding in the pre-hospital setting, with the aim of then transferring the injured patient to a medical facility, where the dressing is removed, underlying injuries assessed and continuing medical care provided.
The purpose of this research study is to collect data on the performance and safety of the Celox Rapid dressing when used in a civilian setting by ambulance personnel in the UK.
In order to capture data relating to the entire period of dressing use, this study will involve both the ambulance service that initially applied the Celox Rapid dressing(s) and the hospital where the patient is transferred to and where the dressing(s) will be removed.
The Celox Rapid dressings will be used in this study in accordance with the approved instructions for use. Only patients with life threatening emergency bleeding that are treated with Celox Rapid will be eligible for inclusion. Data will be captured over the period of use of the dressing, which is expected to be less than 24 hours. Patients will not be required to undergo any additional tests, assessments or questionnaires as a result of participating in this study.
The data generated by the study will help improve the understanding in the wider clinical community of the use and performance of this type of dressing, under normal conditions, in a civilian pre-hospital setting. The results may therefore be of benefit for the general population of future patients who present with life threatening bleeding in this setting.REC name
South Central - Oxford C Research Ethics Committee
REC reference
22/SC/0046
Date of REC Opinion
6 Jul 2022
REC opinion
Further Information Favourable Opinion