The EVARREST® Pediatric Mild or Moderate Liver and Soft Tissue Bleeding Study

Completed · Phase 3

Conditions studied: Controlling Mild to Moderate Bleeding During Surgery

In brief

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.

Key facts

Study ID

NCT03255174

Run by

Ethicon, Inc.

People needed

35

Starts

2018-03-20

Expected to finish

2025-02-14

Last updated by the study team

2026-04-08

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Pediatric subjects aged ≥28 days (≥1 month) to <18 years, requiring non-emergent open hepatic, abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures; i) A minimum of 4 subjects to be enrolled will be aged ≥28 days to <1 year
• The subject's parent/legal guardian must be willing to give permission for the subject to participate in the trial, and provide written Informed Consent for the subject. In addition, assent must be obtained from pediatric subjects who possess the intellectual and emotional ability to comprehend the concepts involved in the trial. If the pediatric subject is not able to provide assent (due to age, maturity and/or inability to intellectually and/or emotionally comprehend the trial), the parent/legal guardian's written Informed Consent for the subject will be acceptable for the subject to be included in the study.
• Presence of an appropriate mild or moderate bleeding soft tissue or hepatic parenchyma Target Bleeding Site (TBS) identified intra-operatively by the surgeon;
• Ability to firmly press trial treatment at TBS until 4 minutes after TBS identification.

You may not qualify if…

• Subjects with known intolerance to blood products or to one of the components of the study product or is unwilling to receive blood products;
• Female subjects, of childbearing age (i.e. adolescent), who are pregnant or nursing;
• Subject is currently participating or plan to participate in any other investigational device or drug study without prior approval from the Sponsor;
• Subjects who are known, current alcohol and/or drug abusers
• Subjects admitted for trauma surgery
• Subjects with any pre or intra-operative findings identified by the surgeon that may preclude conduct of the study procedure
• Subjects that have received a COVID-19 vaccine either 4 weeks prior to surgery or scheduled to receive COVID-19 vaccine within the 30-day follow-up period
• Subject with TBS in an actively infected field (Class III Contaminated or Class IV Dirty or Infected)
• TBS is from large defects in arteries or veins where the injured vascular wall requires repair with maintenance of vessel patency and which would result in persistent exposure of EVARREST to blood flow and pressure during healing and absorption of the product
• TBS with major arterial bleeding requiring suture or mechanical ligation;
• Bleeding site is in, around, or in proximity to foramina in bone, or areas of bony confine.

Where it is running

• University of Alabama Hospital — Birmingham, Alabama, United States
• icahn School of Medicine at Mt Sinai — New York, New York, United States
• Birmingham Chrildren's Hospital — Birmingham, United Kingdom
• Newcastle upon Tyne Hospitals NHS Foundation Trust — Newcastle upon Tyne, United Kingdom
• Southampton University Hospital — Southampton, United Kingdom

Full record on ClinicalTrials.gov

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