REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam

Arsenal Medical

Status: Enrolling

Conditions: Trauma; Hemorrhagic Shock; Shock; Traumatic; Exsanguinating Hemorrhage

Treatments: Device: ResQFoam

Study type: Interventional

Funder types: Industry

Identifiers

NCT02880163

CLIN-030

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 15+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

ResQFoam

Experimental group

Description:

ResQFoam in-vivo expandable foam

Treatment:

Device: ResQFoam