Exsanguinating Hemorrhage, Hemorrhagic Shock, Shock; Traumatic, Trauma
Conditions
Brief 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.
Interventions
DEVICEResQFoam
Hemostatic device for the treatment of emergent, exsanguinating, Class III or IV intraabdominal hemorrhagic shock in subjects due to trauma
Sponsors
Arsenal Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in systolic blood pressure after deployment of ResQFoam over baseline value | 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. |
Countries
United States
Contacts
Primary ContactCarol Pekar, RAC
Outcome results
None listed