PeproStat Haemostat Study in Subjects Undergoing Liver Surgery

Inclusion Criteria: * Are able and willing to provide written informed consent to participate in this study, confirmed by signing the informed consent documents * Adult males and females ≥18 years of age * Female subjects must be post-menopausal. Post-menopausal status is defined as any of the following: natural menopause with menses \>1 year ago; radiation induced oophorectomy with last menses \>1 year ago; chemotherapy induced menopause with 1 year interval since last menses * Willing and able to comply with all protocol requirements including follow-up * Subject must have a haemoglobin ≥ 9.0 g/dL at screening * Subject must have a platelet count ≥ 100,000/mm3 at screening * Subject is undergoing a planned open liver resection * Male subjects must be willing and able to use adequate contraception from enrollment through to the 30 day follow-up visit * During the surgery, the subject presents an identified target bleeding site (TBS) with oozing, mild or moderate bleeding, which conventional surgical techniques are insufficient to control and would otherwise be a candidate for standard haemostats * During the surgery, subject presents no intraoperative complications, other than bleeding, that may interfere with study assessments as judged by the investigator Exclusion Criteria: * Subject is undergoing emergency surgical procedure * Recipient of a liver transplant * Females of child-bearing potential * Active infection at the time of the liver resection * International Normalized Ratio (INR) \> 2.0 or APTT ratio \> 2.0 at screening * Fibrinogen level \< 1.5g/L at screening * History of thromboembolic disease and/or thrombophilia * Any other disease or condition that may affect normal blood clotting, for example thrombocytopenia, as judged by the investigator * A known history of anaphylaxis or allergic reaction to human albumin, PEGylated proteins, yeast or moulds, porcine products or other components in the IMP * Participation in another investigational drug or device research study within 30 days before and after enrolment in the current study * Current known or suspected alcohol and/or drug abuse or dependence at the time of screening * Any concurrent medical, surgical, or psychiatric condition that may, in the investigator's opinion, affect the subject's willingness or ability to meet all study requirements during the study duration * During the surgery, subject presents severe bleeding where use of a topical haemostat would be inappropriate * Subject is taking any prohibited medications * BMI at screening of ≥35