Safety and Efficacy of Activated Recombinant Human Factor VII in Cirrhotic Patients Undergoing Partial Hepatectomy

A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial Evaluating the Safety and Efficacy of A Multi-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Trial Evaluating the Safety and Efficacy of Activated Recombinant Factor VII (rFVIIa/NovoSeven®) in Cirrhotic Patients Scheduled to Undergo Partial Hepatectomy Due to Liver Cancer or Benign Tumours

This trial is conducted in Asia. The aim of this trial is to evaluate the haemostatic efficacy of activated recombinant human factor VII in cirrhotic patients scheduled to undergo partial hepatectomy due to liver cancer or benign tumours.

Inclusion Criteria:

• Cirrhosis (Child-Turcotte Score A, B, or C)
• Scheduled to undergo partial hepatectomy due to liver cancer or benign tumours

Exclusion Criteria:

• Portal vein thrombosis
• Clinically documented DVT (deep venous thrombosis)
• Clinically documented symptoms of severe cardiovascular disease and/or previous myocardial/pulmonary infarction or stroke
• Present renal insufficiency requiring dialysis