| Methods |
Randomised clinical trial. |
| Participants |
Country: Canada.
Sample size: 45.
Post‐randomisation drop‐out(s): not stated.
Revised sample size: 45.
Females: not stated.
Mean age: 49.2 years.
Piggyback: not stated.
Conventional: not stated.
Cadaveric donor: not stated.
Live donor: not stated.
Inclusion criteria:
1. Primary isolated orthotopic liver transplantation between 1992 and 1994.
Exclusion criteria:
1. Patients with primary biliary cirrhosis or primary sclerosing cholangitis.
2. Predisposition to thrombotic tendency.
3. Fulminant liver failure. |
| Interventions |
The patients were randomised to the following groups.
Group 1: intervention (n = 25).
Further details: tranexamic acid 40 mg/kg/hour continuous infusion from induction of anaesthesia to unclamping of portal vein. maximum dose = 20 gram.
Group 2: control (n = 20).
Further details: normal saline. |
| Outcomes |
The outcomes reported were mortality, retransplantation, hospital stay, and transfusion requirements. |
| Notes |
Attempts were made to contact the author in September 2011. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
Quote: "Study agents were prepared by the hospital pharmacy using a randomisation schedule provided in sealed envelopes". |
| Allocation concealment (selection bias) |
Low risk |
Quote: "Study agents were prepared by the hospital pharmacy using a randomisation schedule provided in sealed envelopes; all other personnel were blinded to randomisation status".
Comment: Probably adequate allocation concealment, although details of the sealed envelope such as whether they were opaque and consecutively numbered were not available. |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
Quote: "Study agents were prepared by the hospital pharmacy using a randomisation schedule provided in sealed envelopes; all other personnel were blinded to randomisation status".
Comment: Normal saline was used as placebo. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
Quote: "Study agents were prepared by the hospital pharmacy using a randomisation schedule provided in sealed envelopes; all other personnel were blinded to randomisation status".
Comment: Normal saline was used as placebo. |
| Incomplete outcome data (attrition bias)
All outcomes |
High risk |
Comment: In a preliminary report, the authors had excluded two patients out of 30 patients. |
| Selective reporting (reporting bias) |
High risk |
Comment: Important outcomes were not reported. |
| Vested interest bias |
Unclear risk |
Comment: This information was not available. |
