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REVIVE: 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
Arsenal Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemorrhagic Shock

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

First Posted
August 19, 2016
Last Updated
March 30, 2023
Sponsor
Arsenal Medical, Inc.
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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

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REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam

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