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REVIVE Study: ResQFoam for Severe Internal Bleeding

This study is testing a device called ResQFoam to see if it is safe and effective for treating very severe internal bleeding (exsanguinating intraabdominal hemorrhage) caused by trauma. This type of bleeding is life-threatening and requires immediate surgery. The study is looking for about 40 participants who are 15 years or older and have severe bleeding in their abdomen. Researchers will measure changes in your blood pressure after ResQFoam is used to see how well it works. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 40 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
You will be followed through hospital discharge or for 30 days, whichever comes first.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02880163

REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam

Recruiting
NAAges 15+InterventionalTreatment
Arsenal Medical, Inc.
~40 participants
Updated 2025-11-10 on ClinicalTrials.gov
What's tested:ResQFoam

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in systolic blood pressure after deployment of ResQFoam over baseline value
Measured over 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.

Conditions

Hemorrhagic Shock
Trauma
Exsanguinating Hemorrhage
Shock; Traumatic

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ExsanguinationHemorrhagic ShockInjury

Where it's being run

2 sites across 2 states
Alabama1
Ohio1

Study leadership

  • Timothy Pritts, MD · PRINCIPAL_INVESTIGATOR · University of Cincinnati

Who to contact

Carol Pekar, RAC
[email protected]
508-523-5456
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

What this trial measures

  • Change in systolic blood pressure after deployment of ResQFoam over baseline valueAll 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.