REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam

Recruiting N/A Interventional Study
Hemorrhagic Shock Trauma Exsanguinating Hemorrhage Shock; Traumatic
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
15 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
40 (estimated)
Sponsor
Arsenal Medical, Inc. · Industry
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About This Trial

The purpose of this study is to demonstrate safety, effectiveness and benefit-risk profile of ResQFoam for the inhospital treatment of exsanguinating, intraabdominal haemorrhage due to trauma in patients where emergent laparotomy is required.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Estimated age of 15 years or older (or subject weight estimated at greater than 50 kg if age is unknown) 2. Emergent, exsanguinating hemorrhage, from abdominal source as defined by: * Class III or IV hemorrhagic shock or * Assessment of Blood Consumption (ABC) score ≥ …
Contacts

Carol Pekar, RAC

508-523-5456

cpekar@arsenalmedical.com

CONTACT