The Paediatric EVICEL® Soft Tissue and Parenchymal Organ Bleeding Study
Condition: Hemorrhage; Soft Tissue Bleeding
MeSH terms: Hemorrhage
Intervention: EVICEL® Fibrin Sealant; SURGICEL® Absorbable Hemostat
Intervention description: EVICEL® is a human plasma-derived fibrin sealant. EVICEL® consists of two components: a concentrate of Human Clottable Protein (referred to as Biological Component 2; BAC2) and a solution of Human Thrombin. No material of animal origin is present in the product; SURGICEL® Absorbable Hemostat (oxidized regenerated cellulose) 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
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Fibrin Sealant; Hemostatics; Coagulants

Summary:

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

Eligibility criteria:

        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.