Methods |
Randomised clinical trial. |
Participants |
Country: Italy.
Sample size: 20.
Post‐randomisation drop‐out(s): not stated.
Revised sample size: 20.
Females: not stated.
Mean age: not stated.
Piggyback: not stated.
Conventional: not stated.
Cadaveric donor: not stated.
Live donor: not stated.
Inclusion criteria:
1. Patients undergoing orthotopic liver transplantation. |
Interventions |
The patients were randomised to the following groups.
Group 1: intervention (n = 10).
Further details: rFVIIa 40 mcg/kg as bolus immediately before anaesthesia induction.
Group 2: control (n = 10).
Further details: placebo (details not known). |
Outcomes |
The outcomes reported were mortality, primary graft non‐function, ITU stay, and blood transfusion requirements (the transfusion requirements during the entire operation and immediate post‐operative period was not reported and so this information could not be used). |
Notes |
Attempts were made to contact the authors in September 2011. |
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Comment: This information was not available. |
Allocation concealment (selection bias) |
Unclear risk |
Comment: This information was not available. |
Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Comment: Although the authors state that a placebo was used, they do not state the nature of the placebo or the groups who knew whether the test drug was rFVIIa or placebo. |
Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Comment: Although the authors state that a placebo was used, they do not state the nature of the placebo or the groups who knew whether the test drug was rFVIIa or placebo. |
Incomplete outcome data (attrition bias)
All outcomes |
Unclear risk |
Comment: This information was not available. |
Selective reporting (reporting bias) |
High risk |
Comment: Important outcomes were not reported. |
Vested interest bias |
Unclear risk |
Comment: This information was not available. |