| Methods |
Randomised clinical trial. |
| Participants |
Country: Denmark, Finland, Germany, Spain, USA.
Sample size: 87.
Post‐randomisation drop‐out(s): 4 (4.6%).
Revised sample size: 83.
Females: 26 (29.9%).
Mean age: 50.2 years.
Piggyback: not stated.
Conventional: not stated.
Cadaveric donor: not stated.
Live donor: not stated.
Inclusion criteria:
1. Patients scheduled to undergo orthotopic liver transplantation.
2. Age more than 18 years.
Exclusion criteria:
1. Previous liver transplantation.
2. Multiorgan transplantation.
3. Living related‐donor transplantation.
4. Renal insufficiency requiring dialysis.
5. Documented inherited coagulation disorders.
6. Documented history or presence of portal vein thrombosis. |
| Interventions |
The patients were randomised to the following groups.
Group 1: intervention 1 (n = 22).
Further details of intervention: rFVIIa 80 mcg/Kg as bolus dose within 10 minutes of skin incision.
Group 2: intervention 2 (n = 24).
Further details of intervention: rFVIIa 40 mcg/Kg as bolus dose within 10 minutes of skin incision.
Group 3: intervention 2 (n = 18).
Further details of intervention: rFVIIa 20 mcg/Kg as bolus dose within 10 minutes of skin incision.
Group 3: control (n = 19).
Further details of intervention: placebo (not specified). |
| Outcomes |
The outcomes reported were serious adverse events and blood transfusion requirements. |
| Notes |
Attempts were made to contact the author in September 2011.
Reason for post‐randomisation drop‐out(s): liver transplantation cancelled. |
| 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 placebo was used, the nature of the placebo was not stated. |
| Blinding of outcome assessment (detection bias)
All outcomes |
Unclear risk |
Comment: Although the authors state placebo was used, the nature of the 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 |
Unclear risk |
Comment: This information was not available. |
