Arsenal Medical, Inc.
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.
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…
Hemostatic device for the treatment of emergent, exsanguinating, Class III or IV intraabdominal hemorrhagic shock in subjects due to trauma
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