REVIVE: Reducing Exsanguination Via In-Vivo Expandable Foam
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15+
SponsorArsenal Medical, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Estimated age of 15 years or older (or subject weight estimated at greater than 50 kg if age is unknown)
Class III or IV hemorrhagic shock or
Assessment of Blood Consumption (ABC) score ≥ 2
Direct visualization or
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
ResQFoam
DeviceHemostatic device for the treatment of emergent, exsanguinating, Class III or IV intraabdominal hemorrhagic shock in subjects due to trauma
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: ResQFoamExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov