Shao 2006.

Methods	Randomised clinical trial Sequence generation: unclear. Allocation concealment: unclear. Blinding: adequate. Incomplete outcome data addressed: inadequate. Free of selective reporting: inadequate. Free of other bias: unclear.
Participants	Country: China, Thailand, Taiwan. Number randomised: 235 Post‐randomisation drop‐outs: 14 (6%) (see notes). Mean age: 51.7 years. Females: 38 (17.2%). Major liver resections: not stated. Cirrhotic livers: 235 (100%). Inclusion criteria: > 21 years of age. Cirrhotic patients. Elective liver resection. Exclusion criteria: Portal vein thrombosis or deep vein thrombosis. Severe cardiovascular disease (previous myocardial/pulmonary infarction or stroke). Renal insufficiency requiring dialysis. Anticoagulation therapy within 48 hours of surgery. Life expectancy of < 1 month owing to known metastasis. Other major abdominal surgery planned during the partial hepatectomy. Synchronous liver and intestinal resections. Previous partial hepatectomy.
Interventions	Participants were randomly assigned to three groups. Group 1: rFVIIa 100 mcg/kg (n = 74). Group 2: rFVIIa 50 mcg/kg (n = 71). Group 3: control (n = 76). Further details of intervention: IV drug every 2 hours starting 10 minutes before incision (maximum 4 doses). Other details: Vascular occlusion: not stated. 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	12 patients from all three groups (individual groups not stated) who did not undergo liver resection (n = 11) and who withdrew consent (n = 1) were excluded from analysis. The data of 2 patients in the placebo group were lost. Thus only 221 patients were included for analysis. Attempts to contact the authors in November 2008 were unsuccessful.
Risk of bias
Bias	Authors' judgement	Support for judgement
Adequate sequence generation?	Unclear risk	Unclear.
Allocation concealment?	Unclear risk	Unclear.
Blinding? All outcomes	Low risk	Quote: "Within 10 minutes before the first skin cut, a bolus dose of rFVIIa 50 or 100 g/kg or placebo was administered intravenously over the course of 2 minutes...."
Incomplete outcome data addressed? All outcomes	High risk	Comment: 14 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?	Unclear risk	Unclear.
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?	Unclear risk	Unclear.