RecruitingNot Applicable

REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam

United States40 participantsStarted 2025-08-07

Plain-language 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.

Who can participate

Age range

15 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Estimated age of 15 years or older (or subject weight estimated at greater than 50 kg if age is unknown)
. Emergent, exsanguinating hemorrhage, from abdominal source as defined by:
. Confirmation of abdominal hemorrhage by:
. No other known, uncontrolled active sources of hemorrhage
. Subject is intubated and sedated per local guidelines
. Decision to administer foam is made within 30 minutes of admission to the emergency department.
. Decision made to proceed to emergent laparotomy made within 30 minutes of admission to the emergency department.
. Definitive surgical care is expected to occur within three hours of foam deployment

Exclusion criteria

0. Known or suspected major diaphragm injury
1. Known or suspected untreated pneumothorax
2. Known or suspected untreated hemothorax

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Trial details

NCT IDNCT02880163

SponsorArsenal Medical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-10-31

Contact for this trial

Carol Pekar, RAC

508-523-5456 cpekar@arsenalmedical.com

View on ClinicalTrials.gov More Hemorrhagic Shock trials