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

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…