The EVARREST® Paediatric Mild/Moderate Liver and Soft Tissue Bleeding Study
Condition: Hemorrhage; Soft Tissue Bleeding; Hepatic Parenchyma Bleeding
MeSH terms: Hemorrhage
Intervention: EVARREST™ Sealant Matrix; SURGICEL®
Intervention description: EVARREST® Fibrin Sealant Patch is a sterile, bio-absorbable combination product, comprised of two biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component.; SURGICEL® Absorbable Hemostat is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
Intervention MeSH terms: Fibrin Tissue Adhesive
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 28 Days
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Fibrin Sealant; Hemostatics; Coagulants

Summary:

      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.
    

Eligibility criteria:

        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.