REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam (REVIVE)

Reducing Exsanguination Via In-Vivo Expandable Foam

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.

Study Overview

• Status: Recruiting
• Conditions: Trauma; Hemorrhagic Shock; Exsanguinating Hemorrhage; Shock; Traumatic
• Intervention / Treatment: Device: ResQFoam

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carol Pekar, RAC; Phone Number: 508-523-5456; Email: cpekar@arsenalmedical.com

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • Recruiting
      • University of Alabama at Birmingham
      • Contact: Madison Finch; Phone Number: 205-873-3652; Email: madisonfinch@uabmc.edu
      • Principal Investigator: William P Hewgley, MD
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Recruiting
      • University of Cincinnati
      • Contact: Dina Gomaa, MSc; Phone Number: 513-558-6305; Email: gomaada@ucmail.uc.edu
      • Principal Investigator: Timothy Pritts, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ResQFoam; ResQFoam in-vivo expandable foam	Device: ResQFoam; Hemostatic device for the treatment of emergent, exsanguinating, Class III or IV intraabdominal hemorrhagic shock in subjects due to trauma

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in systolic blood pressure after deployment of ResQFoam over baseline value	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.

Collaborators and Investigators

• Sponsor: Arsenal Medical, Inc.
• Investigators: Principal Investigator: Timothy Pritts, MD, University of Cincinnati

Publications and helpful links

General Publications

• Maegele M. Effective approaches to address noncompressible torso hemorrhage. Curr Opin Crit Care. 2024 Jun 1;30(3):202-208. doi: 10.1097/MCC.0000000000001141. Epub 2024 Feb 28.

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: August 19, 2016
• First Submitted That Met QC Criteria: August 23, 2016
• First Posted (Estimated): August 26, 2016

Study Record Updates

• Last Update Posted (Estimated): November 10, 2025
• Last Update Submitted That Met QC Criteria: November 7, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Shock; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Shock, Hemorrhagic; Shock, Traumatic; Exsanguination
• Other Study ID Numbers: CLIN-030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes