REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam

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:

• 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.

Exclusion criteria

• 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