The Paediatric EVICEL® Soft Tissue and Parenchymal Organ Bleeding Study

A Prospective, Randomized, Controlled Study Evaluating EVICEL® Fibrin Sealant as an Adjunct to Haemostasis During Abdominal, Retroperitoneal, Pelvic or Thoracic (Non-Cardiac) Surgery in Paediatric Patients

To evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) as an adjunct to achieve haemostasis during surgery in paediatric patients.

This is a prospective, randomized, controlled, clinical study comparing EVICEL® to SURGICEL®, as an adjunct to haemostasis when conventional methods of controlling bleeding are ineffective or impractical during surgery in paediatric patients.

At least 40 qualified paediatric subjects with an appropriate mild or moderate Target Bleeding Site (TBS) will be randomized in a 1:1 allocation ratio to either EVICEL® or SURGICEL®. Haemostasis will be assessed at 4, 7 and 10 minutes from randomization.

Enrolment will be staggered by age (as required by the European Medicines Agency (EMA) Paediatric Committee). The first group enrolled will include at least 36 subjects aged ≥1 years to <18 years of age. When enrolment of the first group is complete; enrolment of a subsequent group will commence and include at least 4 subjects from birth (including neonates ≤37 weeks gestation) to <1 years of age.

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

Inclusion Criteria:

• Paediatric subjects birth to <18 years of age, requiring non-emergent laparoscopic or open (through peritoneum or pleura) abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures. i) The first 36 subjects to be enrolled will be subjects ≥1 years to <18 years of age. ii) The next 4 subjects to be enrolled will be subjects birth to <1years of age.
• The subject and/or subject's parent or legal guardian must be willing to give permission for the subject to participate in the trial, and provide written informed consent for the subject. If possible, 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; and
• Presence of an appropriate mild or moderate bleeding soft tissue or parenchymal organ Target Bleeding Site identified intra-operatively by the surgeon;

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, during the study is planned to participate in any other investigational device or drug trial 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 with Target Bleeding Site in an actively infected field (Class III Contaminated or Class IV Dirty or Infected)
• Anastomotic bleeding sites will not be considered for randomization.