Reducing severe bleeding in trauma patients using expandable foam

Reducing Exsanguination Via In-Vivo Expandable Foam

This study tests whether a new foam treatment can help stop severe bleeding in trauma patients with major abdominal injuries before they have surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 15 Years and up
• Sex: All
• Sponsor: Arsenal Medical, Inc. (industry)
• Locations: 2 sites (Birmingham, Alabama and 1 other locations)
• Trial ID: NCT02880163 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and effectiveness of ResQFoam for treating exsanguinating intra-abdominal hemorrhage in trauma patients requiring emergency surgery. Patients aged 15 and older with significant abdominal bleeding will receive the foam within 30 minutes of arriving at the emergency department. The foam is intended to stabilize the patient before definitive surgical intervention, which is expected to occur within three hours of foam application. The study will assess the benefit-risk profile of this innovative treatment approach.

Who should consider this trial

Good fit: Ideal candidates are patients aged 15 years or older experiencing severe abdominal hemorrhage requiring emergency laparotomy.

Not a fit: Patients with uncontrolled active sources of hemorrhage or those not requiring surgical intervention may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce mortality rates associated with traumatic hemorrhagic shock.

How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating this may be a novel intervention.

Eligibility criteria

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

Where this trial is running

Birmingham, Alabama and 1 other locations

• University of Alabama at Birmingham — Birmingham, Alabama, United States (RECRUITING)
• University of Cincinnati — Cincinnati, Ohio, United States (RECRUITING)

Study contacts

• Principal investigator: Timothy Pritts, MD — University of Cincinnati
• Study coordinator: Carol Pekar, RAC

Conditions: Hemorrhagic Shock, Trauma, Exsanguinating Hemorrhage, Shock, Traumatic