REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam

Eligibility 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 ≥ 2
• 3. Confirmation of abdominal hemorrhage by:
• * Direct visualization or
• * Positive Focused Assessment with Sonography in Trauma (FAST) or
• * Diagnostic Peritoneal Aspiration (DPA)
• 4. No other known, uncontrolled active sources of hemorrhage
• 5. Subject is intubated and sedated per local guidelines
• 6. Decision to administer foam is made within 30 minutes of admission to the emergency department.
• 7. Decision made to proceed to emergent laparotomy made within 30 minutes of admission to the emergency department.
• 8. Definitive surgical care is expected to occur within three hours of foam deployment
• 9. Subject must also be receiving concurrent transfusion of fluids or blood products.
• 10. Known or suspected major diaphragm injury
• 11. Known or suspected untreated pneumothorax
• 12. Known or suspected untreated hemothorax
• 13. Known or suspected blunt or penetrating cardiac or thoracic aortic trauma
• 14. Traumatic brain injury resulting in decapitation, visible brain matter or considered non- survivable based on initial physical exam
• 15. Received greater than five consecutive minutes of cardiopulmonary resuscitation in the pre-emergency department setting
• 16. Patients with Pulseless Electrical Activity
• 17. Known allergy to isocyanate
• 18. Known or suspected pregnancy
• 19. History of prior abdominal surgery or evidence of abdominal surgery (scars)
• 20. Disrupted abdominal wall that, in the opinion of the investigator would preclude ResQFoam from being adequately contained within the abdominal cavity
• 21. Subject in whom the abdominal aortic junctional tourniquet (AAJT) or Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) techniques have been used
• 22. Known Prisoners
• 23. Subjects with burns \> 20% of total body surface area
• 24. Subject/legally authorized representative/subject family member purposefully opted out of participation in the study
• 25. Known Do Not Resuscitate order (DNR) or Physician Orders for Life Sustaining Treatment (POLST)
• 26. Known enrollment in another randomized, interventional study