Clinical trial NCT02880163: REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam
Official title: Reducing Exsanguination Via In-Vivo Expandable Foam
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemorrhagic Shock
Trauma
Exsanguinating Hemorrhage
Shock; Traumatic
Lead sponsor: Arsenal Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2016-08-26
Enrollment: 40
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


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

Primary outcomes:
measure: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Timothy Pritts, MD
role: PRINCIPAL_INVESTIGATOR
References: