ResQFoam for Severe Abdominal Bleeding

(REVIVE Trial)

Recruiting at 2 trial locations

Overseen By Carol Pekar, RAC

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Arsenal Medical, Inc.

Must be taking: Fluids, Blood products

Disqualifiers: Diaphragm injury, Pneumothorax, Hemothorax, Cardiac trauma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: In-hospital treatment

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of ResQFoam, a special expandable foam, for treating severe abdominal bleeding caused by trauma. It focuses on patients needing emergency surgery due to significant abdominal bleeding. Suitable candidates have severe abdominal bleeding, require immediate surgery, and must be receiving fluids or blood transfusions. The trial seeks to determine if ResQFoam can manage bleeding quickly and safely in hospital settings. As an unphased trial, it offers patients the opportunity to contribute to pioneering research that could enhance emergency care for severe abdominal bleeding.

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 prior data suggests that ResQFoam is safe for treating severe abdominal bleeding?

Research has shown that ResQFoam can be safe for treating severe abdominal bleeding. Studies have found that it expands inside the body to apply pressure on the bleeding area and stop it. However, some problems, such as issues with the intestines, have been reported. This indicates that while ResQFoam has potential, side effects can occur. Overall, it appears to be a promising treatment, but like any medical procedure, it carries risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

ResQFoam is unique because it uses an in-vivo expandable foam to control severe abdominal bleeding. Unlike traditional methods like surgical intervention or external compression, ResQFoam is injected into the body, where it expands to form a temporary internal barrier that helps control bleeding from the inside. This novel delivery method could provide rapid stabilization of patients, potentially reducing the time to definitive surgical care and improving survival rates. Researchers are excited about ResQFoam because it offers a new way to manage life-threatening bleeding, especially in situations where traditional treatments are too slow or impractical.

What evidence suggests that ResQFoam is effective for severe abdominal bleeding?

Research has shown that ResQFoam can help treat severe abdominal bleeding. Studies have found that this foam, which expands on its own when injected into the abdomen, can slow or stop bleeding. This is crucial in emergencies where quick action is needed. Previous research suggests that ResQFoam can be a safe and effective way to treat life-threatening bleeding in the pelvic area. Although some complications might occur, its ability to manage severe bleeding is promising. This trial tests ResQFoam for safety and effectiveness in hospitals. ^{1 2 3 4 6}

Who Is on the Research Team?

Timothy Pritts, MD

Principal Investigator

University of Cincinnati

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• ResQFoam

Trial Overview 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.

How Is the Trial Designed?

Group I: ResQFoam Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Arsenal Medical, Inc.

Lead Sponsor

Trials

1

Recruited

40+

Published Research Related to This Trial

In cases of massive abdominal bleeding due to trauma, controlling the source of bleeding and optimizing hemostasis are critical for improving survival rates.

The use of recombinant activated factor VII (rFVIIa) in six patients who did not respond to standard treatments showed promising results, contributing to a good survival rate, highlighting its potential role in managing severe hemorrhage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies to control massive abdominal bleeding. Busani, S., Cavazzuti, I., Marietta, M., et al.[2016]

In a study of 17 patients who experienced postoperative bleeding after major abdominal surgery, the use of rfVIIa effectively controlled bleeding in 94% of cases without the need for re-operation.

The administration of rfVIIa significantly reduced the need for blood transfusions and corrected coagulopathy, demonstrating its potential as a safe and effective intervention in managing postoperative hemorrhage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of factor VII in correcting dilutional coagulopathy and reducing re-operations for bleeding following non-traumatic major gastrointestinal and abdominal surgery. Tsai, TC., Rosing, JH., Norton, JA.[2021]

Gelfoam powder was effective in controlling massive gastric bleeding in 10 out of 14 patients, particularly those with lesions supplied by the embolized left gastric artery, highlighting its efficacy in specific cases.

However, complications occurred in 2 patients with compromised vascular supply, indicating that Gelfoam should be used cautiously and is best suited for patients with localized small-vessel lesions and intact vascular supply.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gelfoam powder embolization of the left gastric artery in treatment of massive small-vessel gastric bleeding. Rösch, J., Keller, FS., Kozak, B., et al.[2016]

In a post-hoc analysis of two trials involving coagulopathic trauma patients, those treated with recombinant factor VIIa (rFVIIa) required significantly fewer blood products, including a reduction of 3.5 units of red blood cells among survivors after 48 hours.

rFVIIa treatment also led to a lower incidence of multi-organ failure and acute respiratory distress syndrome (3% in rFVIIa group vs. 20% in placebo), indicating its potential efficacy in improving outcomes for coagulopathic patients without increasing thromboembolic events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recombinant activated factor VII as an adjunctive therapy for bleeding control in severe trauma patients with coagulopathy: subgroup analysis from two randomized trials. Rizoli, SB., Boffard, KD., Riou, B., et al.[2022]

In a study involving 75 subjects undergoing 105 cardiovascular surgeries, BioFoam Surgical Matrix effectively achieved hemostasis within 3 minutes for 84% of patients and within 10 minutes for 93%, demonstrating its efficacy as an adjunct for controlling bleeding.

The safety profile of BioFoam was acceptable, with only 16% of subjects experiencing adverse events, none of which were linked to the product, and only 5.3% requiring reoperation for bleeding within 24 hours, indicating it is a safe option for surgical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of BioFoam for Anastomotic Bleeding in Cardiovascular Surgery. Alfieri, O.[2023]

In a study involving four swine, the combination of Gelfoam and human thrombin was significantly more effective at controlling post-operative bleeding compared to Gelfoam and saline, with notable improvements observed at 3, 6, and 12 minutes after treatment.

The results suggest that human thrombin may be a safer alternative to traditional bovine thrombin, warranting further investigation into its efficacy and safety in comparison to other hemostatic agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute in-vivo evaluation of bleeding with Gelfoam plus saline and Gelfoam plus human thrombin using a liver square lesion model in swine. Adams, GL., Manson, RJ., Hasselblad, V., et al.[2021]

Recombinant human factor VIIa (rFVIIa) was successfully used to manage severe noncompressible abdominal hemorrhage in two postoperative patients, a dog and a cat, who had ongoing bleeding despite receiving massive transfusions and antifibrinolytic therapy.

The administration of rFVIIa, given intravenously every 3 hours at doses of 70 to 90 μg/kg, effectively reduced the need for further blood transfusions, highlighting its potential as a critical intervention in veterinary emergency care for severe hemorrhage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of recombinant human factor VIIa in 2 patients with postoperative noncompressible, abdominal hemorrhage. Zorn, CM., Blong, AE., Walton, R.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11831287/

Self-expanding foam injected into the peritoneal space ... This study demonstrates that ResQFoam can be a safe and effective intervention for lethal pelvic hemorrhage when deployed intra-abdominally. HOW ...

2. tsaco.bmj.com tsaco.bmj.com/content/10/1/e001791.full

Self-expanding foam for pelvic retroperitoneal hemorrhage Mortality from pelvic fracture-related hemorrhage has been reported to be over 30% based on the latest multicenter review from Duchesne et ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2590006425009354

Injectable Hemostatic Foam Hydrogel for Traumatic Intra- ... For example, ResQFoam has been reported to treat abdominal hemorrhage(21). However, it brings some complications (including intestinal pressure ...

4. clinicaltrials.keckmedicine.org clinicaltrials.keckmedicine.org/clinicaltrials/909

Effect of ResQFoam to Slow or Stop Severe Internal Bleeding ... This clinical study is about whether ResQFoam can help slow or stop severe internal bleeding in the abdomen (belly area) while the patient is being brought in ...

5. sjtrem.biomedcentral.com sjtrem.biomedcentral.com/articles/10.1186/s13049-023-01088-8

Traumatic hemorrhage and chain of survival ResQFoam is currently under clinical trial review to demonstrate the safety, effectiveness, and benefit-risk profile for the treatment of ...

6. giving.massgeneral.org giving.massgeneral.org/stories/foam-stops-traumatic-bleeding

Surgeon Develops Foam to Stop Traumatic Bleeding ResQFoam is injected into the body, and it quickly expands to fill the abdominal cavity, applying pressure that may stabilize the patient. King ...