REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam
NCT ID: NCT02880163
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
40 participants
INTERVENTIONAL
2025-08-07
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ResQFoam
ResQFoam in-vivo expandable foam
ResQFoam
Hemostatic device for the treatment of emergent, exsanguinating, Class III or IV intraabdominal hemorrhagic shock in subjects due to trauma
Interventions
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ResQFoam
Hemostatic device for the treatment of emergent, exsanguinating, Class III or IV intraabdominal hemorrhagic shock in subjects due to trauma
Eligibility Criteria
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Inclusion Criteria
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
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
15 Years
ALL
No
Sponsors
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Arsenal Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Timothy Pritts, MD
Role: PRINCIPAL_INVESTIGATOR
University of Cincinnati
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University of Cincinnati
Cincinnati, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Madison Finch
Role: primary
Dina Gomaa, MSc
Role: primary
References
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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.
Other Identifiers
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CLIN-030
Identifier Type: -
Identifier Source: org_study_id