REVIVE: Reducing Exsanguination Via In‐Vivo Expandable Foam (REVIVE)

This study is not yet open for participant recruitment.

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Contacts and Locations

Verified June 2017 by Arsenal Medical, Inc.

Sponsor:

Information provided by (Responsible Party):

Arsenal Medical, Inc.

ClinicalTrials.gov Identifier:

NCT02880163

First received: August 19, 2016

Last updated: June 8, 2017

Last verified: June 2017

History of Changes

Purpose

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.

Condition	Intervention	Phase
Hemorrhagic Shock Trauma Exsanguinating Hemorrhage Shock; Traumatic	Device: ResQFoam	Phase 1


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: No masking Primary Purpose: Treatment
Official Title:	Reducing Exsanguination Via In‐Vivo Expandable Foam

Resource links provided by NLM:

MedlinePlus related topics: Caffeine

U.S. FDA Resources

Further study details as provided by Arsenal Medical, Inc.:

Primary Outcome Measures:

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. ]


Estimated Enrollment:	40
Anticipated Study Start Date:	December 2018
Estimated Study Completion Date:	July 2019
Estimated Primary Completion Date:	June 2019 (Final data collection date for primary outcome measure)

Intervention Details:

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

Eligibility


Ages Eligible for Study:	15 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided

More Information


Responsible Party:	Arsenal Medical, Inc.
ClinicalTrials.gov Identifier:	NCT02880163 History of Changes
Other Study ID Numbers:	CLIN-032
Study First Received:	August 19, 2016
Last Updated:	June 8, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes


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
Pediatric Postmarket Surveillance of a Device Product:		No

Additional relevant MeSH terms:


Hemorrhage Shock Shock, Hemorrhagic Exsanguination	Shock, Traumatic Pathologic Processes Wounds and Injuries

ClinicalTrials.gov processed this record on July 13, 2017

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