Lodge 2005.

Methods	Randomised clinical trial Sequence generation: adequate. Allocation concealment: adequate. Blinding: adequate. Incomplete outcome data addressed: inadequate. Free of selective reporting: inadequate. Free of other bias: inadequate.
Participants	Country: France, Germany, Spain, United Kingdom. Number randomised: 204. Post‐randomisation drop‐out: 19 (9.3%) (see notes). Mean age: 56.5 years. Females: 92 (49.7%). Major liver resections: not stated. Cirrhotic livers: 0 (0%). Inclusion criteria: Adults. Non‐cirrhotic. Liver resections. Exclusion criteria: Hereditary bleeding disorders. Planned use of autologous blood transfusion. Ant‐coagulation therapy within 48 hours before hepatectomy. Use of tissue glue. Hemodilution therapy. Hemostatic drugs for prophylactic purposes. Renal insufficiency requiring dialysis. Portal vein or deep vein thrombosis within the preceding 6 months. Severe cardiovascular disease or myocardial/pulmonary infarction or stroke within the preceding 6 months. Active bleeding. Use of nonsteroidal antiinflammatory drugs within 7 days before surgery.
Interventions	Participants were randomly assigned to three groups. Group 1: rFVIIa 80 mcg/kg (n = 59). Group 2: rFVIIa 20 mcg/kg (n = 63). Group 3: control (n = 63). Further details of intervention: IV drug 5 minutes before incision and repeated at 5 hours if anticipated operating time > 6 hours. Other details: Vascular occlusion: PTC (in 64.9%). Method of parenchymal transection: not stated. Management of raw surface: not stated. Other co‐interventions to decrease blood loss: none reported.
Outcomes	The outcome measures were mortality, transfusion requirements, peri‐operative morbidity, operating time, and blood loss.
Notes	19 patients from all three groups (individual groups not stated) in whom drug was not administered (n = 4) and in those who did not undergo liver resection after the drug was administered (n = 15) were excluded from analysis. Attempts to contact the authors in November 2008 were unsuccessful.
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	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?	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? All outcomes	Low risk	Quote: "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 addressed? All outcomes	High risk	Comment: 19 patients were excluded post‐randomisation. This could be related to the treatment effect.
Free of selective reporting?	High risk	Comment: Important outcomes such as liver failure were not reported.
Free of baseline imbalance?	Low risk	Yes.
Free of early stopping bias?	Low risk	Comment: The trialists recruited the intended number of patients.
Free of academic bias?	Low risk	Comment: There were no previously published trials of same comparisons by the author.
Free of sponsor 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."