ResQFoam for Exsanguinating Trauma Abdominal Haemorrhage
Research type
Research Study
Full title
REVIVE: Reducing Exsanguination Via in vivo Expandable Foam
IRAS ID
212017
Contact name
Upma Sharma
Contact email
Sponsor organisation
Arsenal Medical, Inc.
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
2016-003145-28, EudraCT
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
In subjects who are severely injured and experiencing uncontrolled abdominal bleeding, rapid haemorrhage control is critical to preserve survival. Delays in immediate care can increase the risk of trauma related death. In order to address this unmet clinical need, Arsenal Medical has developed ResQFoam, a novel device for control of emergent haemorrhage within the abdomen. ResQFoam is intended to be used in the hospital as a device to aid and treat severe bleeding within the abdomen. This is a single arm, multi-centre clinical trial designed to evaluate the safety and clinical efficacy of ResQFoam through the measurement of an improved systolic blood pressure following intervention. Additionally, this study will evaluate the safety of ResQFoam through the assessment of all adverse events with discrimination of those directly attributed to the use of the device. This study will take place in Major Trauma centres.
REC name
South Central - Oxford C Research Ethics Committee
REC reference
16/SC/0473
Date of REC Opinion
6 Dec 2016
REC opinion
Further Information Favourable Opinion