Actively Recruiting
REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam
Led by Arsenal Medical, Inc. · Updated on 2025-11-10
40
Participants Needed
2
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is 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.
CONDITIONS
Official Title
REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Estimated age of 15 years or older or weight greater than 50 kg if age unknown
- Emergent, severe abdominal bleeding with Class III or IV hemorrhagic shock or ABC score of 2 or higher
- Abdominal hemorrhage confirmed by direct visualization, positive Focused Assessment with Sonography in Trauma (FAST), or Diagnostic Peritoneal Aspiration (DPA)
- No other uncontrolled active bleeding sources
- Patient is intubated and sedated according to local guidelines
- Decision to use ResQFoam made within 30 minutes of emergency department admission
- Decision to proceed with emergent laparotomy made within 30 minutes of emergency department admission
- Definitive surgery expected within three hours after foam deployment
- Patient must be receiving fluid or blood transfusions concurrently
You will not qualify if you...
- Known or suspected major diaphragm injury
- Known or suspected untreated pneumothorax
- Known or suspected untreated hemothorax
- Known or suspected blunt or penetrating cardiac or thoracic aortic trauma
- Traumatic brain injury causing decapitation, visible brain matter, or non-survivable condition based on exam
- More than five consecutive minutes of cardiopulmonary resuscitation before emergency department arrival
- Patients with pulseless electrical activity
- Known allergy to isocyanate
- Known or suspected pregnancy
- History or evidence of prior abdominal surgery
- Disrupted abdominal wall preventing containment of ResQFoam
- Use of abdominal aortic junctional tourniquet (AAJT) or Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA)
- Known prisoners
- Burns covering more than 20% of total body surface area
- Patient or legal representative opted out of study participation
- Presence of Do Not Resuscitate (DNR) or Physician Orders for Life Sustaining Treatment (POLST)
- Enrollment in another randomized, interventional study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Actively Recruiting
Research Team
C
Carol Pekar, RAC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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