A Safety and Efficacy Study Comparing Fibrocaps and Tachosil in Hepatic Surgery

Exclusion Criteria

• •1. Subject has known hypersensitivity to Fibrocaps or any of its components
• •2. Subject has known allergy to porcine gelatin
• •3. Subject has known hypersensitivity to Tachosil or any of the excipients included in Tachosil
• •4. Subject is unwilling to receive blood products
• •5. Subject is having hepatic surgery due to emergency-traumatic event
• •6. Subject requires extrahepatic bile duct resection (common bile duct resection or resection of the bile duct which leads to performing an anastomoses between the bile duct and small bowel) and biliary anastomosis, and/or pancreatic resections
• •7. Subject 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, or baseline abnormalities of international normalized ratio (INR) \> 2.5 or activated partial thromboplastin time (aPTT) \> 100 seconds during screening that are not explained by current drug treatment (e.g., warfarin, heparin)
• •8. Subject has a platelet count \< 100 x10\^9 PLT/L during screening
• •9. Subject has medical, social or psychosocial factors that, in the opinion of the investigator, could impact safety or compliance with study procedures
• •10. Subject is 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 within 6 weeks after surgery