REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam

Study Overview
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Brief Summary
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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.

Official Title
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Reducing Exsanguination Via In-Vivo Expandable Foam

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

Intervention / Treatment
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* Device: ResQFoam


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Estimated age of 15 years or older (or subject weight estimated at greater than 50 kg if age is unknown) Emergent, exsanguinating hemorrhage, from abdominal source as defined by: Class III or IV hemorrhagic shock or Assessment of Blood Consumption (ABC) score ≥ 2 Confirmation of abdominal hemorrhage by: Direct visualization or Positive Focused Assessment with Sonography in Trauma (FAST) or Diagnostic Peritoneal Aspiration (DPA) No other known, uncontrolled active sources of hemorrhage Subject is intubated and sedated per local guidelines Decision to administer foam is made within 30 minutes of admission to the emergency department. Decision made to proceed to emergent laparotomy made within 30 minutes of admission to the emergency department. Definitive surgical care is expected to occur within three hours of foam deployment Subject must also be receiving concurrent transfusion of fluids or blood products. Exclusion Criteria: Known or suspected major diaphragm injury Known or suspected untreated pneumothorax Known or suspected untreated hemothorax Known or suspected blunt or penetrating cardiac or thoracic aortic trauma Traumatic brain injury resulting in decapitation, visible brain matter or considered non- survivable based on initial physical exam Received greater than five consecutive minutes of cardiopulmonary resuscitation in the pre-emergency department setting Patients with Pulseless Electrical Activity Known allergy to isocyanate Known or suspected pregnancy History of prior abdominal surgery or evidence of abdominal surgery (scars) Disrupted abdominal wall that, in the opinion of the investigator would preclude ResQFoam from being adequately contained within the abdominal cavity Subject in whom the abdominal aortic junctional tourniquet (AAJT) or Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) techniques have been used Known Prisoners Subjects with burns > 20% of total body surface area Subject/legally authorized representative/subject family member purposefully opted out of participation in the study Known Do Not Resuscitate order (DNR) or Physician Orders for Life Sustaining Treatment (POLST) Known enrollment in another randomized, interventional study

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ResQFoam<br>ResQFoam in-vivo expandable foam | Device: ResQFoam<br>* Hemostatic device for the treatment of emergent, exsanguinating, Class III or IV intraabdominal hemorrhagic shock in subjects due to trauma<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |