The EVARREST® Paediatric Mild/Moderate Liver and Soft Tissue Bleeding Study

A Prospective, Randomized, Controlled, Study Evaluating the Safety and Effectiveness of EVARREST® Sealant Matrix in Controlling Mild or Moderate Hepatic Parenchyma or Soft Tissue Bleeding During Open Abdominal, Retroperitoneal, Pelvic and Thoracic (Non-cardiac) Surgery in Paediatric Patients

The objective of this study is to evaluate the safety and effectiveness of EVARREST™ Sealant Matrix (EVARREST™ Fibrin Sealant Patch) (EVARREST™) in controlling mild or moderate soft tissue & parenchymal bleeding during open hepatic, abdominal, pelvic, retroperitoneal, and thoracic (non-cardiac) surgery in paediatric patients.

This is an open label, prospective, randomised, multicentre, controlled, clinical study comparing EVARREST to SURGICEL (oxidized regenerated cellulose (ORC)) (Control) as an adjunct to haemostasis when conventional methods of controlling mild or moderate bleeding are ineffective or impractical during surgery in paediatric patients.

At least 40 qualified paediatric subjects with an appropriate mild or moderate bleeding Target Bleeding Site (TBS) will be randomised in a 1:1 allocation ratio to either EVARREST or SURGICEL (control). Absolute time to haemostasis will be assessed as well as haemostasis at 4 and 10 minutes from randomisation.

Enrolment will be staggered by age (as required by the European Medicines Agency (EMA) Paediatric Committee). The first 36 subjects enrolled will be aged ≥1 years to <18 years of age. Enrolment of a subsequent group will include 4 subjects from 1 month (≥ 28 days from birth) to <1 year of age will follow. Ongoing safety assessment will ensure adequate safety monitoring occur during the staged enrolment.

Subjects will be followed post-operatively through hospital discharge and at 30 days (+/-14 days) post-surgery.

Inclusion Criteria:

• Paediatric subjects aged ≥28 days (≥ 1 month) to <18 years, requiring non-emergent open hepatic, abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures. i) The first 36 subjects to be enrolled will be subjects aged ≥1 years to <18 years. ii) The next 4 subjects to be enrolled will be subjects 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 paediatric subjects who possess the intellectual and emotional ability to comprehend the concepts involved in the trial. If the paediatric 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 randomisation

Exclusion Criteria:

• 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, who are of childbearing age (i.e. adolescent), who are pregnant or nursing;
• Subject is currently participating or plans to participate in any other investigational device or drug 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.
• 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 the EVARREST™ or SURGICEL® 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.