ResQFoam for Severe Abdominal Bleeding

(REVIVE Trial)

Recruiting at1 trial location

Overseen by Timothy Pritts, MD

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?

The research on recombinant activated factor VII (rFVIIa), a different treatment, shows it can help control bleeding in severe trauma cases, suggesting that treatments like ResQFoam might also be effective in managing severe abdominal bleeding. ^{1 2 3 4 5}

How is the treatment ResQFoam unique for severe abdominal bleeding?

ResQFoam is unique because it is designed to rapidly expand and fill the abdominal cavity, providing internal pressure to control bleeding, unlike traditional methods that rely on external compression or surgical intervention. ^{2 3 4 6 7}

Research Team

Timothy Pritts, MD

Principal Investigator

University of Cincinnati

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.

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.

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 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.

Participant Groups

Group I: ResQFoam Experimental Treatment 1 Intervention

ResQFoam in-vivo expandable foam

Who Is Running the Clinical Trial?

Arsenal Medical, Inc.

Lead Sponsor

Trials

1

Recruited

40+

Findings from Research

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 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 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]

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 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]

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]

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]

References

1. England 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Strategies to control massive abdominal bleeding. [2016]

3. Netherlands 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. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

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

5. United States 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. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Use of recombinant human factor VIIa in 2 patients with postoperative noncompressible, abdominal hemorrhage. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Gelfoam powder embolization of the left gastric artery in treatment of massive small-vessel gastric bleeding. [2016]