RECRUITING

REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam

Conditions

Hemorrhagic Shock Trauma Exsanguinating Hemorrhage Shock; Traumatic

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Reducing Exsanguination Via In-Vivo Expandable Foam

Quick Facts

Study Start:2024-06-28

Study Completion:2025-07-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT02880163

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:15 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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

Inclusion Criteria

Exclusion 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.

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

Contacts and Locations

Study Contact

Carol Pekar, RAC

CONTACT

508-523-5456

cpekar@arsenalmedical.com

Principal Investigator

Timothy Pritts, MD

PRINCIPAL_INVESTIGATOR

University of Cincinnati

Study Locations (Sites)

University of Cincinnati

Cincinnati, Ohio, 45219

United States

Collaborators and Investigators

Sponsor: Arsenal Medical, Inc.

Timothy Pritts, MD, PRINCIPAL_INVESTIGATOR, University of Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-28

Study Completion Date2025-07-28

Study Record Updates

Study Start Date2024-06-28

Study Completion Date2025-07-28

Terms related to this study

Additional Relevant MeSH Terms

Hemorrhagic Shock
Trauma
Exsanguinating Hemorrhage
Shock; Traumatic