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Expandable Foam
ResQFoam for Severe Abdominal Bleeding (REVIVE Trial)
N/A
Waitlist Available
Research Sponsored by Arsenal Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Definitive surgical care is expected to occur within three hours of foam deployment
Emergent, exsanguinating hemorrhage, from abdominal source as defined by: Class III or IV hemorrhagic shock or Assessment of Blood Consumption (ABC) score ≥ 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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.
Awards & highlights
REVIVE Trial Summary
This trial will study whether ResQFoam is safe and effective for treating severe abdominal bleeding in trauma patients who need emergency surgery.
Who is the study for?
The REVIVE trial is for patients aged 15 or older with severe, life-threatening abdominal bleeding from trauma requiring emergency surgery. They must be intubated and sedated, in shock due to blood loss, and not have other uncontrolled bleeding sources. Exclusions include burns over 20% of the body, known pregnancy, prior abdominal surgery, certain medical orders like DNRs, allergies to isocyanate or participation in another interventional study.Check my eligibility
What is being tested?
This trial tests ResQFoam's safety and effectiveness for hospital treatment of critical intraabdominal hemorrhage due to trauma when urgent laparotomy (abdominal surgery) is needed. The foam aims to control bleeding until surgical care can be provided within three hours of its use.See study design
What are the potential side effects?
Potential side effects may include allergic reactions specifically related to an allergy to isocyanate (a component of the foam), complications from foam containment issues if there are pre-existing conditions like disrupted abdominal wall or major diaphragm injuries.
REVIVE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I will have surgery within 3 hours after a specific treatment is applied.
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I am experiencing severe bleeding from my abdomen.
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I do not have any uncontrolled bleeding.
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My abdominal bleeding was confirmed by a doctor using a special test.
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I am currently receiving blood or fluid transfusions.
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I am currently on a breathing machine and sedated according to local guidelines.
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I was decided for emergency abdominal surgery within 30 minutes of ER arrival.
REVIVE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Body Weight Changes
REVIVE Trial Design
1Treatment groups
Experimental Treatment
Group I: ResQFoamExperimental Treatment1 Intervention
ResQFoam in-vivo expandable foam
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Who is running the clinical trial?
Arsenal Medical, Inc.Lead Sponsor
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a serious injury to my diaphragm.The decision to use foam treatment was made within 30 minutes of my emergency room visit.I will have surgery within 3 hours after a specific treatment is applied.I am experiencing severe bleeding from my abdomen.I do not have any uncontrolled bleeding.I might have an untreated collapsed lung.I received CPR for more than 5 minutes before arriving at the hospital.I have undergone AAJT or REBOA techniques for emergency care.I have burns covering more than 20% of my body.I or my legal representative have chosen not to participate in this study.I am at least 15 years old or weigh more than 50 kg if my age is unknown.I have had surgery in my abdomen before.I might have blood in the chest that hasn't been treated.My abdominal bleeding was confirmed by a doctor using a special test.I am currently receiving blood or fluid transfusions.I have had a blunt or penetrating injury to my heart or the main artery in my chest.I am currently on a breathing machine and sedated according to local guidelines.I was decided for emergency abdominal surgery within 30 minutes of ER arrival.
Research Study Groups:
This trial has the following groups:- Group 1: ResQFoam
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies to join this clinical trial?
"According to clinicaltrials.gov, this trial is not presently enrolling patients. Initially posted on April 1st 2023 and recently revised as of July 26th 2022, the study has no current vacancies; however, 556 other studies are actively seeking participants."
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