Back to resultsREVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam (REVIVE)
Primary Purpose
Hemorrhagic Shock, Trauma, Exsanguinating Hemorrhage
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ResQFoam
Sponsored by
About this trial
This is an interventional treatment trial for Hemorrhagic Shock
Eligibility Criteria
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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ResQFoam
Arm Description
ResQFoam in-vivo expandable foam
Outcomes
Primary Outcome Measures
Change in systolic blood pressure after deployment of ResQFoam over baseline value
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02880163
Brief Title
REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam
Acronym
REVIVE
Official Title
Reducing Exsanguination Via In-Vivo Expandable Foam
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 1, 2023 (Anticipated)
Primary Completion Date
October 1, 2024 (Anticipated)
Study Completion Date
December 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Arsenal Medical, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemorrhagic Shock, Trauma, Exsanguinating Hemorrhage, Shock; Traumatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ResQFoam
Arm Type
Experimental
Arm Description
ResQFoam in-vivo expandable foam
Intervention Type
Device
Intervention Name(s)
ResQFoam
Intervention Description
Hemostatic device for the treatment of emergent, exsanguinating, Class III or IV intraabdominal hemorrhagic shock in subjects due to trauma
Primary Outcome Measure Information:
Title
Change in systolic blood pressure after deployment of ResQFoam over baseline value
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carol Pekar, RAC
Phone
508-523-5456
Email
cpekar@arsenalmedical.com
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Renne
Phone
617-468-1518
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam
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