Hemorrhagic ShockREVIVENCT02880163
REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam
A study testing ResQFoam in people with Hemorrhagic Shock and Trauma, run by Arsenal Medical, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Hemorrhagic Shock, Trauma, Exsanguinating Hemorrhage
- What is being tested?
- ResQFoam
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Aug 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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:
- Class III or IV hemorrhagic shock or
- Assessment of Blood Consumption (ABC) score ≥ 2
- Confirmation of abdominal hemorrhage by:
- Direct visualization or
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- Positive Focused Assessment with Sonography in Trauma (FAST) or
- Diagnostic Peritoneal Aspiration (DPA)
- 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
- Subject must also be receiving concurrent transfusion of fluids or blood products.
Who cannot join
- 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 resulting in decapitation, visible brain matter or considered non- survivable based on initial physical exam
- Received greater than five consecutive minutes of cardiopulmonary resuscitation in the pre-emergency department setting
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- Patients with Pulseless Electrical Activity
- Known allergy to isocyanate
- Known or suspected pregnancy
- History of prior abdominal surgery or evidence of abdominal surgery (scars)
- Disrupted abdominal wall that, in the opinion of the investigator would preclude ResQFoam from being adequately contained within the abdominal cavity
- Subject in whom the abdominal aortic junctional tourniquet (AAJT) or Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) techniques have been used
- Known Prisoners
- Subjects with burns > 20% of total body surface area
- Subject/legally authorized representative/subject family member purposefully opted out of participation in the study
- Known Do Not Resuscitate order (DNR) or Physician Orders for Life Sustaining Treatment (POLST)
- Known enrollment in another randomized, interventional study
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Madison Finch, 205-873-3652, madisonfinch@uabmc.edu
William P Hewgley, MD
- Recruiting
University of Cincinnati
Cincinnati, Ohio, 45219
Dina Gomaa, MSc, 513-558-6305, gomaada@ucmail.uc.edu
Timothy Pritts, MD
About this study
Official title: 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.
- Conditions
- Hemorrhagic Shock, Trauma, Exsanguinating Hemorrhage, Shock; Traumatic
- Being tested
- ResQFoam
- Medical subject headings
- Shock, Hemorrhagic, Wounds and Injuries, Exsanguination, Shock, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ResQFoamDevice
Hemostatic device for the treatment of emergent, exsanguinating, Class III or IV intraabdominal hemorrhagic shock in subjects due to trauma
| Study group | Role | What they receive |
|---|---|---|
| ResQFoam | Experimental | ResQFoam in-vivo expandable foam Receives: Device: ResQFoam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in systolic blood pressure after deployment of ResQFoam over baseline value
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study start7 Aug 2025
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hemorrhagic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arsenal Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy Pritts, MD, Principal investigator, University of Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02880163
- Sponsor's protocol ID
- CLIN-030
- Acronym
- REVIVE
- Status last verified
- Nov 2025
- First submitted
- 19 Aug 2016
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
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.
PubMed 38441108
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Exsanguination Via In-Vivo Expandable Foam
- ClinicalTrials.gov ID
- NCT02880163
- Acronym / sponsor ID
- REVIVE / CLIN-030
- Conditions
- Hemorrhagic Shock, Trauma, Exsanguinating Hemorrhage, Shock; Traumatic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Arsenal Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- 7 Aug 2025 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ResQFoam | Experimental | Device: ResQFoamResQFoam in-vivo expandable foam |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (17 listed)
- 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 resulting in decapitation, visible brain matter or considered non- survivable based on initial physical exam
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ResQFoamHemostatic device for the treatment of emergent, exsanguinating, Class III or IV intraabdominal hemorrhagic shock in subjects due to trauma | Device | ResQFoam |
Primary outcome
Change in systolic blood pressure after deployment of ResQFoam over baseline value
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Derived from this study: PubMed 38441108Maegele 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Timothy Pritts, MD principal investigator
University of Cincinnati
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ResQFoam in people with Hemorrhagic Shock and Trauma, run by Arsenal Medical, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carol Pekar, RAC (508-523-5456, cpekar@arsenalmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systolic blood pressure after deployment of ResQFoam over baseline value (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02880163, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.