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.
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