REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Outcome Measures
Primary Outcome Measures
- 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.]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Estimated age of 15 years or older (or subject weight estimated at greater than 50 kg if age is unknown)
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Emergent, exsanguinating hemorrhage, from abdominal source as defined by:
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Class III or IV hemorrhagic shock or
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Assessment of Blood Consumption (ABC) score ≥ 2
- Confirmation of abdominal hemorrhage by:
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Direct visualization or
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Positive Focused Assessment with Sonography in Trauma (FAST) or
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Diagnostic Peritoneal Aspiration (DPA)
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No other known, uncontrolled active sources of hemorrhage
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Subject is intubated and sedated per local guidelines
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Decision to administer foam is made within 30 minutes of admission to the emergency department.
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Decision made to proceed to emergent laparotomy made within 30 minutes of admission to the emergency department.
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Definitive surgical care is expected to occur within three hours of foam deployment
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Subject must also be receiving concurrent transfusion of fluids or blood products.
Exclusion Criteria:
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Known or suspected major diaphragm injury
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Known or suspected untreated pneumothorax
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Known or suspected untreated hemothorax
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Known or suspected blunt or penetrating cardiac or thoracic aortic trauma
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Traumatic brain injury resulting in decapitation, visible brain matter or considered non- survivable based on initial physical exam
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Received greater than five consecutive minutes of cardiopulmonary resuscitation in the pre-emergency department setting
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Patients with Pulseless Electrical Activity
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Known allergy to isocyanate
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Known or suspected pregnancy
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History of prior abdominal surgery or evidence of abdominal surgery (scars)
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Disrupted abdominal wall that, in the opinion of the investigator would preclude ResQFoam from being adequately contained within the abdominal cavity
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Subject in whom the abdominal aortic junctional tourniquet (AAJT) or Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) techniques have been used
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Known Prisoners
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Subjects with burns > 20% of total body surface area
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Subject/legally authorized representative/subject family member purposefully opted out of participation in the study
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Known Do Not Resuscitate order (DNR) or Physician Orders for Life Sustaining Treatment (POLST)
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Known enrollment in another randomized, interventional study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
Sponsors and Collaborators
- Arsenal Medical, Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLIN-030