| Methods |
Randomised clinical trial. |
| Participants |
Country: France.
Sample size: 189.
Post‐randomisation drop‐out(s): not stated.
Revised sample size: 189.
Females: not stated.
Mean age: 43.5 years.
Piggyback: not stated.
Conventional: not stated.
Cadaveric donor: not stated.
Live donor: not stated.
Inclusion criteria:
1. Adult patients undergoing primary orthotopic liver transplantation.
Exclusion criteria:
1. Retransplantation |
| Interventions |
The patients were randomised to the following groups.
Group 1: intervention (n = 94).
Further details: aprotinin 2 million KIU bolus on induction followed by continuous infusion of 0.5 million KIU until transfer to ITU.
Group 2: control (n = 95).
Further details: aprotinin 0.5 million KIU bolus on induction followed by continuous infusion of 150,000 KIU until transfer to ITU. |
| Outcomes |
The outcomes reported were blood transfusion requirements. |
| 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) |
Low risk |
Quote: "Using a computer‐generated list of random numbers, patients were assigned to receive norepinephrine (vasopressor group) or IV fluids and isotonic saline (placebo group) by the research coordinator, who had no part in the clinical management of patients". |
| Allocation concealment (selection bias) |
Low risk |
Quote: "Using a computer‐generated list of random numbers, patients were assigned to receive norepinephrine (vasopressor group) or IV fluids and isotonic saline (placebo group) by the research coordinator, who had no part in the clinical management of patients". |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote: "The blinding of the investigators to isotonic saline or norepinephrine was done by the Department of Pharmacy at the UMDNJ. Blinding was maintained throughout the study period by pharmacists, who had no role in the clinical management of the study patients and data collection. The vasopressor and placebo were both colorless fluids". |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: "The blinding of the investigators to isotonic saline or norepinephrine was done by the Department of Pharmacy at the UMDNJ. Blinding was maintained throughout the study period by pharmacists, who had no role in the clinical management of the study patients and data collection. The vasopressor and placebo were both colorless fluids". |
| 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. |
