Age: Any Age
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: Arsenal Medical, Inc.
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.
Is the treatment ResQFoam a promising treatment for severe abdominal bleeding?The information provided does not directly mention ResQFoam, but it highlights the importance of new treatments for controlling severe abdominal bleeding. Since ResQFoam is being studied for this purpose, it could be a promising treatment if it effectively controls bleeding like other successful methods mentioned.134712
What safety data exists for ResQFoam for severe abdominal bleeding?The provided research does not contain specific safety data for ResQFoam or its use in treating severe abdominal bleeding. The articles focus on adverse events related to other medical treatments, such as therapies for inflammatory bowel disease and the use of hemostatic agents in surgery, but do not mention ResQFoam.6891011
What data supports the idea that ResQFoam for Severe Abdominal Bleeding is an effective treatment?The available research does not provide specific data on ResQFoam for Severe Abdominal Bleeding. However, it mentions other treatments like recombinant activated factor VII (rFVIIa), which showed good survival rates in patients with massive abdominal bleeding who did not respond to standard treatments. This suggests that innovative treatments can be effective in managing severe bleeding.23457
Do I have to stop taking my current medications for the trial?The trial protocol does not specify whether you need to stop taking your current medications. However, since the trial involves emergency treatment for severe abdominal bleeding, it's likely that your current medications will be managed by the medical team based on your condition.
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
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.
My abdominal bleeding was confirmed by a doctor using a special test.
I am currently receiving blood or fluid transfusions.
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.
Exclusion Criteria
I have had surgery in my abdomen before.
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.
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 might have blood in the chest that hasn't been treated.
I have had a blunt or penetrating injury to my heart or the main artery in my chest.
Treatment Details
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.
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
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.
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.
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.
Safety of biological therapies in ulcerative colitis: An umbrella review of meta-analyses. [2022]Biological agents have proven clinical efficacy in the treatment of ulcerative colitis (UC). Their adverse effects have also been studied in a substantial number of primary studies and meta-analyses. Given the large volume of information that has been published, the aim of this umbrella review was to effectively summarize the accumulated evidence from randomized controlled trials (RCTs) on the safety of biological therapies for UC into one accessible and usable document. Pubmed and Scopus databases were systematically searched through November 2017 to identify meta-analyses of RCTs that have investigated potential harms of biological agents (adalimumab, golimumab, infliximab, and vedolizumab) in patients with UC. Ten eligible meta-analyses were included. The body of available evidence supports the safety of biologic therapies in UC. Further research is needed to clarify the risk of any infection with biologics, for elderly and high-risk groups, for longer-term effects, and for head-to-head comparisons between the different biologics.
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.
Adverse events in IBD therapy: the 2018 update. [2019]Crohn's disease and ulcerative colitis affect an increasing number of patients, and utilization of immune suppressant and biologic therapies is also increasing. These agents are linked to adverse events ranging from mild nuisance symptoms to potentially life-threatening complications including infections and malignancies. Areas covered: This review provides an updated discussion on adverse events associated with immunomodulator, anti-TNF-α, anti-integrin, and anti-IL 12/IL-23 antibody therapies. In addition, we review the risk profile of the currently widely available infliximab biosimilar medication. Expert commentary: Providers should engage in risk-benefit discussion with information specific to each medication discussed, and consider individualized risk factors when selecting therapeutic agents. Drug monitoring and shared decision-making results in more personalized medical management of inflammatory bowel disease.
Comparison of signal detection of tumour necrosis factor-α inhibitors using the Korea Adverse Events Reporting System Database, 2005-2016. [2022]There are no pharmacovigilance studies on adverse event (AE) data for tumour necrosis factor alpha (TNFα) inhibitors in South Korea. We analysed AEs induced by adalimumab, infliximab, and etanercept METHODS: We used data from the Korea Institute of Drug Safety and Risk Management-Korea Adverse Events Reporting System Database (KIDS-KD) collected between 2005 and 2016. We used three different signal detection methods: proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC). The drug was compared with drug labels in the USA and Korea. Logistic regression analysis identified AEs that are more likely to occur with drug use.
Analysis of adverse events with sclerosants reported to the United States Food and Drug Administration. [2022]To analyze adverse events (AEs) related to sclerosants reported through the Federal Adverse Event Reporting System (FAERS).
Exploring Adverse Events and Utilization of Topical Hemostatic Agents in Surgery. [2022]This retrospective study provides preliminary qualitative assessment of the adverse events (AEs), focusing on pelvic and abdominal AEs and patient outcomes reported for three hemostatic agents used in gynecologic 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.