REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam

Launched by ARSENAL MEDICAL, INC. · Aug 23, 2016

Keywords

ClinConnect Summary

The REVIVE clinical trial is studying a new foam treatment called ResQFoam for patients who are experiencing severe abdominal bleeding due to trauma. This foam is designed to help control bleeding when surgical intervention (emergency surgery) is needed quickly. The goal of the study is to evaluate how safe and effective this foam is for patients who are in critical condition, specifically those showing signs of significant blood loss.

To be eligible for this trial, participants must be at least 15 years old and have a serious abdominal hemorrhage that requires immediate medical attention. They should also be receiving blood or fluids to help with their condition. If someone decides to take part in the study, they can expect to receive the foam treatment shortly after arriving at the emergency department, and their condition will be closely monitored as they prepare for surgery. It’s important to know that certain patients, such as those with specific injuries or medical conditions, may not be able to participate in this trial.

Gender

ALL

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 ≥ 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.
• Exclusion Criteria:
• • 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