A Study of Fibrocaps in Liver Surgery in the Netherlands

Exclusion Criteria

• •1. Pregnant or lactating women
• •2. Has a known intolerance to blood products or to Fibrocaps components
• •3. Unwilling to receive human blood products
• •4. Subject has a known allergy to porcine gelatin
• •5. Has a mental or physical condition that would, in the opinion of the Investigator, place the subject at an unacceptable risk or render the subject unable to meet the requirements of the protocol
• •6. Currently participating or has participated in another clinical study involving another investigational agent within 4 weeks of the planned date of surgery, or is planning participation in another clinical trial during the 4 weeks after surgery
• •7. Has any clinically-significant coagulation disorder that may interfere with the assessment of efficacy or pose a safety risk to the subject according to the Investigator
• •8. Platelets(PLT) \< 100 x109 PLT/L during screening
• •9. Activated Partial Thromboplastin Time (aPTT) \> 100 seconds during screening
• •10. International Normalized Ratio (INR) \> 2.5 during screening