EVARREST Patch for Pediatric Surgical Bleeding
Trial Summary
What is the purpose of this trial?
The objective of this study is to evaluate the safety and hemostatic effectiveness of EVARREST as an adjunct to controlling mild to moderate soft hepatic parenchyma or soft tissue bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery in pediatric population.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
What data supports the effectiveness of the EVARREST treatment for pediatric surgical bleeding?
Research shows that the EVARREST Fibrin Sealant Patch is effective in controlling bleeding during surgeries, such as liver resections, by forming a stable clot to stop bleeding. Fibrin sealants, like EVARREST, have been used successfully in various surgeries to reduce blood loss and improve recovery.12345
Is the EVARREST Patch safe for use in humans?
How is the EVARREST Patch treatment for pediatric surgical bleeding different from other treatments?
The EVARREST Patch is unique because it combines a fibrin sealant with a patch to control bleeding during surgery. This combination allows it to adhere to tissue and provide a physical barrier, which is different from other treatments that may only use a liquid sealant or rely on traditional methods like sutures.35789
Eligibility Criteria
This trial is for pediatric patients aged 1 month to <18 years needing non-emergency surgery for mild or moderate liver and soft tissue bleeding. It's not for kids with major arterial bleeding, pregnant adolescents, drug abusers, trauma surgery patients, those with certain pre-operative conditions, recent or upcoming COVID-19 vaccinations, participation in other trials without approval, intolerance to blood products or infected surgical sites.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Eligible subjects will be treated with EVARREST Fibrin Sealant Patch during surgery to control mild or moderate bleeding
Follow-up
Participants are monitored for safety and effectiveness after treatment, including adverse events and laboratory test abnormalities
Treatment Details
Interventions
- EVARREST® Fibrin Sealant Patch
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ethicon, Inc.
Lead Sponsor
Tim Schmid
Ethicon, Inc.
Chief Executive Officer since 2023
Undergraduate degree from the University of Western Ontario, MBA from Richmond University in the United Kingdom
Nancy Sabin
Ethicon, Inc.
Chief Medical Officer
MBA from the University of Pennsylvania’s Wharton School of Business, B.S. in Engineering from Duke University