REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam

Trauma Clinical Trial

— REVIVE  

Official title:

Reducing Exsanguination Via In-Vivo Expandable Foam

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02880163
• Other study ID #: CLIN-030
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: March 2023
• Source: Arsenal Medical, Inc.
• Contact: Carol Pekar, RAC
• Phone: 508-523-5456
• Email: cpekar[@]arsenalmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 1, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Exsanguinating Hemorrhage
• Hemorrhage
• Hemorrhagic Shock
• Shock
• Shock, Hemorrhagic
• Shock; Traumatic
• Trauma

Intervention

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

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Arsenal Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.