Lodge 2005.

Methods	Randomised clinical trial
Participants	Country: European multicentre trial Number randomised: 204 Postrandomisation dropouts: 19 (9.3%) Revised sample size: 185 Average age: 57 years Women: 92 (49.7%) Number of cirrhotics: 0 (0%) Number of major liver resections: not stated Number of right hepatectomies: not stated Follow‐up (months): until discharge Further details of methods of liver resection Vascular occlusion: mixture of methods Parenchymal transection: not stated Fibrin glue: no Pharmacological methods: factor being randomised Cardiopulmonary methods: not stated Autologous transfusion: no Inclusion criteria Non‐cirrhotic adults (≥ 18 years of age) scheduled to undergo partial hepatectomy for liver cancer/metastasis, benign tumors, or both Planned anatomical resection of 3 or more segments of the liver or planned nonanatomical resection of a volume equivalent to 2 or more segments of the liver parenchyma Exclusion criteria Known hereditary bleeding disorders The planned use of autologous blood transfusion Low molecular weight heparin before hepatectomy Tissue glue or haemodilution therapy during surgery or haemostatic drugs for prophylactic purposes Renal insufficiency requiring dialysis Clinically documented portal vein or deep vein thrombosis or a history of the latter within the preceding 6 months Severe cardiovascular disease or previous myocardial/pulmonary infarction or stroke within the preceding 6 months Anticoagulation therapy not discontinued within 48 h before surgery Active bleeding Use of nonsteroidal antiinflammatory drugs within 7 d before surgery
Interventions	Participants were randomly assigned to 2 groups. Group 1: recombinant factor viia (n = 126) Group 2: control (n = 59) Recombinant factor VIIa: first dose: slow intravenous injection (20 mcg/kg or 80 mcg/kg) within 5 min before incision. Second dose: identical dose was given 5 h after incision if the surgery time was anticipated to exceed 6 h Control: placebo
Outcomes	The outcomes reported were: short‐term mortality, long‐term mortality, proportion of people with serious adverse events, number of serious adverse events, number of adverse events, operative blood loss, proportion of people requiring blood transfusion, quantity of blood transfused (red cell transfusion or whole blood), and operating time.
Notes	Reasons for postrandomisation dropouts: did not receive drug (n = 4); did not undergo hepatectomy (n = 15)
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "Randomization was computer‐generated and was performed after patient eligibility assessments on the day of surgery by means of a central interactive voice response system set up by Novo Nordisk A/S".
Allocation concealment (selection bias)	Low risk	Quote: "Randomization was computer‐generated and was performed after patient eligibility assessments on the day of surgery by means of a central interactive voice response system set up by Novo Nordisk A/S".
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "The current randomized, controlled, double‐blind, multi‐national trial was designed to evaluate the efficacy and safety of rFVIIa in noncirrhotic patients undergoing major liver resection. To maintain blinding, an equal volume of trial drug per body weight was administered to all patients, irrespective of treatment group allocation".
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: "The current randomized, controlled, double‐blind, multi‐national trial was designed to evaluate the efficacy and safety of rFVIIa in noncirrhotic patients undergoing major liver resection. To maintain blinding, an equal volume of trial drug per body weight was administered to all patients, irrespective of treatment group allocation".
Incomplete outcome data (attrition bias) All outcomes	High risk	Comment: there were postrandomisation dropouts.
Selective reporting (reporting bias)	Low risk	Comment: mortality and morbidity were reported.
Vested interest bias	High risk	Quote: "The authors thank the patients and the hospital staff participating in the trial, as well as Allan Blemings, M.Sc. (Statistician), and Karsten Soendergaard, M.Sc. (Clinical Researcher), both at Novo Nordisk A/S, Copenhagen, Denmark".
Other bias	Low risk	Comment: no other bias