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Recruiting NCT02880163

REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam

No phase Interventional Hemorrhagic Shock Trauma Exsanguinating Hemorrhage Shock; Traumatic

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ResQFoam.
Who it may be relevant to
Registry conditions: Hemorrhagic Shock, Trauma, Exsanguinating Hemorrhage, Shock; Traumatic. Basic parameters: from 15 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Reducing Exsanguination Via In-Vivo Expandable Foam

Overview

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.

Interventions

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

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.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • University of Alabama at Birmingham — Birmingham
  • University of Cincinnati — Cincinnati

Publications

  • 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

Identifiers

NCT: NCT02880163 · CLIN-030

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗