Reducing Exsanguination Via In-Vivo Expandable Foam
Arsenal Medical, Inc.
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.
Eligibility
- Age range
- 15+ years
- Sex
- All
- Healthy volunteers
- No
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 guid…
Interventions
- DeviceResQFoam
Hemostatic device for the treatment of emergent, exsanguinating, Class III or IV intraabdominal hemorrhagic shock in subjects due to trauma
Locations (2)
- University of Alabama at BirminghamBirmingham, Alabama
- University of CincinnatiCincinnati, Ohio