| Methods |
Randomised clinical trial. |
| Participants |
Country: Germany.
Sample size: 20.
Post‐randomisation drop‐out(s): 2 (10%).
Revised sample size: 18.
Females: not stated.
Mean age: 50 years.
Piggyback: not stated.
Conventional: not stated.
Cadaveric donor: not stated.
Live donor: not stated.
Inclusion criteria:
1. Patients undergoing primary elective orthotopic liver transplantation. |
| Interventions |
The patients were randomised to the following groups.
Group 1: intervention (n = 9).
Further details: aprotinin 2 million KIU loading dose after induction of anaesthesia, followed by continuous infusion of 500,000 KIU/ hour until the end of procedure.
Group 2: control (n = 9).
Further details: placebo. |
| Outcomes |
The outcomes reported were blood transfusion requirements. |
| Notes |
Attempts were made to contact the authors in September 2011.
Reason for post‐randomisation drop‐out(s): death, massive surgical haemorrhage (group not stated). |
| 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 a placebo was used, the nature of the placebo was not stated. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Comment: Although a placebo was used, the nature of the placebo was not stated. |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Quote: "Two patients had to be excluded from statistical evaluation because of massive surgical haemorrhage and death during the study period". |
| Selective reporting (reporting bias) |
High risk |
Comment: Important outcomes were not reported. |
| Vested interest bias |
Unclear risk |
Comment: This information was not available. |
