| Methods |
Randomised clinical trial. |
| Participants |
Country: Finland, Italy, Netherlands, Sweden.
Sample size: 141.
Post‐randomisation drop‐out(s): 5 (3.5%).
Revised sample size: 136.
Females: 33 (23.4%).
Mean age: 51.4 years.
Piggyback: not stated.
Conventional: not stated.
Cadaveric donor: not stated.
Live donor: not stated.
Inclusion criteria:
1. Patients who underwent primary orthotopic transplantation for acute or chronic liver disease.
2. Age at least 18 years.
Exclusion criteria:
1. Retransplantation.
2. Known or suspected exposure to aprotinin.
3. Malignant disease.
4. pre‐existing thrombotic conditions. |
| Interventions |
The patients were randomised to the following groups.
Group 1: intervention 1 (n = 45).
Further details of intervention: 2 million KIU aprotinin as a loading dose given intravenously over 20 min before and during induction of anaesthesia, followed by a continuous infusion of 1 million KIU/hour until 2 hours after graft reperfusion. An additional dose of one million KIU was given half an hour before reperfusion.
Group 2: intervention 2 (n = 43).
Further details of intervention: 2 million KIU aprotinin as a loading dose given intravenously over 20 min before and during induction of anaesthesia, followed by a continuous infusion of 0.5 million KIU/hour until 2 hours after graft reperfusion.
Group 3: control (n = 48).
Further details: placebo (not stated). |
| Outcomes |
The outcomes reported were mortality, primary graft non‐function, retransplantation, reoperation, adverse effects, ITU stay, and blood transfusion requirements. |
| Notes |
Attempts were made to contact the authors in September 2011.
Reason for post‐randomisation drop‐out(s): protocol violation (5); allergic reaction (1). |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Comment: From the other details available in this trial, it is highly likely that the authors used an appropriate method of random sequence generation. |
| Allocation concealment (selection bias) |
Low risk |
Quote: "The trial drug was provided double blind by the manufacturer in blocks of 12 identical case packs. Each case pack contained all bottles for one patient, identifiable only by the sequence number". |
| Blinding of participants and personnel (performance bias)
All outcomes |
Unclear risk |
Quote: "The trial drug was provided double blind by the manufacturer in blocks of 12 identical case packs. Each case pack contained all bottles for one patient, identifiable only by the sequence number".
Comment: The nature of placebo was not stated. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Quote: "The trial drug was provided double blind by the manufacturer in blocks of 12 identical case packs. Each case pack contained all bottles for one patient, identifiable only by the sequence number".
Comment: The nature of placebo was not stated. |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Comment: There were post‐randomisation drop‐outs. |
| Selective reporting (reporting bias) |
High risk |
Comment: Important outcomes were not reported. |
| Vested interest bias |
High risk |
Quote: "Aprotinin and placebo were donated by Bayer, Wuppertal, Germany". |
