ResQFoam for Severe Abdominal Bleeding
(REVIVE Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Arsenal Medical, Inc.
Must be taking: Fluids, Blood products
Disqualifiers: Diaphragm injury, Pneumothorax, Hemothorax, Cardiac trauma, others
No Placebo Group
Approved in 1 Jurisdiction
Trial Summary
What is the purpose of 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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment ResQFoam for severe abdominal bleeding?
Eligibility Criteria
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.Inclusion Criteria
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.
See 6 more
Exclusion Criteria
I have a serious injury to my diaphragm.
I might have an untreated collapsed lung.
I received CPR for more than 5 minutes before arriving at the hospital.
See 14 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive ResQFoam for the treatment of exsanguinating, intraabdominal haemorrhage due to trauma
In-hospital treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Treatment Details
Interventions
- ResQFoam (Expandable Foam)
Trial OverviewThis 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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: ResQFoamExperimental Treatment1 Intervention
ResQFoam in-vivo expandable foam
ResQFoam is already approved in United States for the following indications:
🇺🇸 Approved in United States as ResQFoam for:
- Exsanguinating, intra-abdominal hemorrhage due to trauma
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of CincinnatiCincinnati, OH
Massachusetts General HospitalBoston, MA
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Who Is Running the Clinical Trial?
Arsenal Medical, Inc.Lead Sponsor
References
Recombinant activated factor VII as an adjunctive therapy for bleeding control in severe trauma patients with coagulopathy: subgroup analysis from two randomized trials. [2022]We conducted a post-hoc analysis on the effect of recombinant factor VIIa (rFVIIa) on coagulopathic patients from two randomized, placebo-controlled, double-blind trials of rFVIIa as an adjunctive therapy for bleeding in patients with severe trauma.
Strategies to control massive abdominal bleeding. [2016]Abdominal trauma is divided into blunt and penetrating causes. Massive intraabdominal hemorrhage after injury represents the most dangerous precipitating factor that can affect survival if not promptly managed. The first target to achieve management of bleeding patients is control of the source, and then adequate resuscitation and optimization of hemostasis. New procoagulant drugs as recombinant activated factor VII (rFVIIa) seem to play an interesting role in bleeding control after trauma. Our experience with rFVIIa in six patients who were refractory to standard treatments demonstrated a good survival rate after massive abdominal bleeding. Regardless of new drugs and new technologies, a multidisciplinary approach is the cornerstone of the primary care of the these patients.
Acute in-vivo evaluation of bleeding with Gelfoam plus saline and Gelfoam plus human thrombin using a liver square lesion model in swine. [2021]Management of post-operative bleeding has historically used topical bovine thrombin. However, possible harm through activation of coagulation inhibitors has encouraged investigation with other hemostatic agents. This study utilized a novel ordinal bleeding model to test whether a Gelfoam + human thrombin solution is superior at controlling bleeding when compared to Gelfoam + saline solution at different time intervals.
Evaluation of BioFoam for Anastomotic Bleeding in Cardiovascular Surgery. [2023]Hemostatic agents are increasingly used as an adjunct to standard methods of controlling anastomotic bleeding in surgical procedures. The purpose of this study was to investigate the safety and effectiveness of BioFoam Surgical Matrix used as an adjunct for anastomotic hemostasis following cardiovascular surgery.
Role of factor VII in correcting dilutional coagulopathy and reducing re-operations for bleeding following non-traumatic major gastrointestinal and abdominal surgery. [2021]The objective of this study is to evaluate the effectiveness of rfVIIa in reducing blood product requirements and re-operation for postoperative bleeding after major abdominal surgery.
Use of recombinant human factor VIIa in 2 patients with postoperative noncompressible, abdominal hemorrhage. [2023]To describe the clinical presentation, clinical course, and successful management of noncompressible, abdominal hemorrhage with recombinant human factor VIIa (rFVIIa) in 2 postoperative patients.
Gelfoam powder embolization of the left gastric artery in treatment of massive small-vessel gastric bleeding. [2016]Gelfoam (gelatin foam) powder was used for embolization therapy of massive gastric bleeding from small vessels in 14 patients with severe underlying medical problems. Bleeding was controlled in 10 patients with lesions localized in areas supplied by the embolized left gastric artery. In four patients with concurrent lesions in other portions of the stomach, bleeding decreased only (3 patients) or did not respond to embolization (1 patient). Complications developed in 2 patients with compromised vascular supply of the stomach: superficial ischemic ulcers that healed, and a large ulcer that perforated and required surgery. Microscopic studies demonstrated Gelfoam powder penetration mostly into vessels 100 to 200 microns in diameter and only occasionally into smaller vessels 50 to 60 microns, with occlusion of approximately 10 to 15% of the vasculature. It is concluded that Gelfoam fragments are the primary embolic material to be used for occlusion of the left gastric artery. Use of Gelfoam powder should be limited to occasional patients who have only little chance of responding to Gelfoam fragment embolization. Potential candidates for Gelfoam powder embolization include patients with major coagulopathies and/or uremia who massively hemorrhage from small-vessel lesions localized in upper portions of the stomach, exhibit significant mucosal hypervascularity, and do not respond to selective vasopressin treatment. An uncompromised vascular supply of the stomach is a precondition of a safe left gastric artery embolization.