REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam
United States40 participantsStarted 2025-08-07
Plain-language summary
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.
Who can participate
Age range15 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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:
✓. Confirmation of abdominal hemorrhage by:
✓. 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
Exclusion criteria
✕0. Known or suspected major diaphragm injury
✕1. Known or suspected untreated pneumothorax
✕2. Known or suspected untreated hemothorax
✕3. Known or suspected blunt or penetrating cardiac or thoracic aortic trauma
✕4. Traumatic brain injury resulting in decapitation, visible brain matter or considered non- survivable based on initial physical exam
What they're measuring
1
Change in systolic blood pressure after deployment of ResQFoam over baseline value
Timeframe: All SBP assessments prior to deployment of IP through removal of IP and completion of laparotomy. Patient will be followed through hospital discharge or through Day 30, whichever comes first.