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Foam that stops bleeding from the inside: new trial underway

NCT ID NCT02880163

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This trial tests a device called ResQFoam, an expandable foam injected into the abdomen to stop severe internal bleeding caused by trauma. The study involves 40 people with life-threatening hemorrhagic shock who need emergency surgery. The goal is to see if the foam can safely raise blood pressure and control bleeding until surgery can be performed.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ResQFoam (expandable foam device)
What this could lead to
If successful, this foam could quickly stop life-threatening abdominal bleeding in trauma patients, buying time for surgery and improving survival.
What could go wrong
This is an early study with only 40 participants, so results may not apply to all patients. The foam could cause complications like increased abdominal pressure or fail to control bleeding.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

15 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Estimated age of 15 years or older (or subject weight estimated at greater than 50 kg if age is unknown) 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: 10. Known or suspected major diaphragm injury 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

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Conditions

The condition(s) this trial relates to.

Exsanguination injury Shock, Hemorrhagic Shock, Traumatic

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Alabama at Birmingham

    RECRUITING

    Birmingham, Alabama, 35294, United States

  • University of Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45219, United States

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