REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam

NCT02880163 | Recruiting DMC FDA Device

• 1 other identifier: CLIN-030
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Hemorrhagic Shock; Trauma; Exsanguinating Hemorrhage; Shock; Traumatic

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

ResQFoam

EXPERIMENTAL

ResQFoam in-vivo expandable foam

Device: ResQFoam

Interventions

ResQFoam DEVICE

Hemostatic device for the treatment of emergent, exsanguinating, Class III or IV intraabdominal hemorrhagic shock in subjects due to trauma

ResQFoam

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Arsenal Medical, Inc.: lead

Study Sites (2)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

RECRUITING

University of Cincinnati

Cincinnati, Ohio, 45219, United States

RECRUITING

Related Publications (1)

• Maegele M. Effective approaches to address noncompressible torso hemorrhage. Curr Opin Crit Care. 2024 Jun 1;30(3):202-208. doi: 10.1097/MCC.0000000000001141. Epub 2024 Feb 28.

  PMID: 38441108 DERIVED

MeSH Terms

Conditions

Shock, Hemorrhagic; Wounds and Injuries; Exsanguination; Shock, Traumatic

Condition Hierarchy (Ancestors)

Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Timothy Pritts, MD

  University of Cincinnati

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carol Pekar, RAC

CONTACT

508-523-5456; cpekar@arsenalmedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2016
• First Posted: August 26, 2016
• Study Start: August 7, 2025
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

US (2)