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New treatment option for Hemorrhagic Shock
Official title REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam
ClinicalTrials.gov ID: NCT02880163
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 15 and older
You may be able to join 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:
You likely can't join 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
See the full eligibility 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.
- 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
- people 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 assigned by chance, treatment study
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Cincinnati, Ohio, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 15 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Cincinnati, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.