REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam
Recruiting now · Not applicable
Conditions studied: Hemorrhagic Shock, Trauma, Exsanguinating Hemorrhage, Shock; Traumatic
In brief
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.
Key facts
- Study ID
- NCT02880163
- Run by
- Arsenal Medical, Inc.
- People needed
- 40
- Starts
- 2025-08-07
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2025-11-10
Who can join
Age: 15 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Estimated age of 15 years or older (or subject weight estimated at greater than 50 kg if age is unknown)
- Emergent, exsanguinating hemorrhage, from abdominal source as defined by:
- Class III or IV hemorrhagic shock or
- Assessment of Blood Consumption (ABC) score ≥ 2
- Confirmation of abdominal hemorrhage by:
- Direct visualization or
- Positive Focused Assessment with Sonography in Trauma (FAST) or
- Diagnostic Peritoneal Aspiration (DPA)
- No other known, uncontrolled active sources of hemorrhage
- Subject is intubated and sedated per local guidelines
- Decision to administer foam is made within 30 minutes of admission to the emergency department.
- Decision made to proceed to emergent laparotomy made within 30 minutes of admission to the emergency department.
- Definitive surgical care is expected to occur within three hours of foam deployment
- Subject must also be receiving concurrent transfusion of fluids or blood products.
You may not qualify if…
- Known or suspected major diaphragm injury
- Known or suspected untreated pneumothorax
- Known or suspected untreated hemothorax
- Known or suspected blunt or penetrating cardiac or thoracic aortic trauma
- Traumatic brain injury resulting in decapitation, visible brain matter or considered non- survivable based on initial physical exam
- Received greater than five consecutive minutes of cardiopulmonary resuscitation in the pre-emergency department setting
- Patients with Pulseless Electrical Activity
- Known allergy to isocyanate
- Known or suspected pregnancy
- History of prior abdominal surgery or evidence of abdominal surgery (scars)
- Disrupted abdominal wall that, in the opinion of the investigator would preclude ResQFoam from being adequately contained within the abdominal cavity
- Subject in whom the abdominal aortic junctional tourniquet (AAJT) or Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) techniques have been used
- Known Prisoners
- Subjects with burns > 20% of total body surface area
- Subject/legally authorized representative/subject family member purposefully opted out of participation in the study
- Known Do Not Resuscitate order (DNR) or Physician Orders for Life Sustaining Treatment (POLST)
- Known enrollment in another randomized, interventional study
Where it is running
- University of Alabama at Birmingham — Birmingham, Alabama, United States (enrolling)
- University of Cincinnati — Cincinnati, Ohio, United States (enrolling)
Full record on ClinicalTrials.gov
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