Orthotopic liver transplantation can be associated with excessive blood loss.
As a result, there may be increased risk of adverse outcomes.
Activated recombinant factor VII has demonstrated the ability to improve hemostasis in a variety of disorders.
However, there has been a limited amount of research into its use in orthotopic liver transplantation.
Dr Sukru Emre and colleagues conducted a double-blind trial in patients with end-stage liver disease undergoing orthotopic liver transplantation.
| The number of adverse events between the study groups was comparable|
The team randomized patients to 1 of 4 parallel study groups to examine dose, efficacy, and safety of activated recombinant factor VII in reducing bleeding.
Patients received a single intravenous bolus of activated recombinant factor VII prior to surgery, at a dose of 20 g/kg in Group1 and 40 g/kg in Group 2.
The team gave Group 3 80 g/kg of a single intravenous bolus of activated recombinant factor VII, while Group 4 received a placebo prior to surgery.
The primary assessment endpoint was the total number of red blood cell units transfused perioperatively.
The research team evaluated safety by adverse events reported.
The team reported that 83 comparable patients were randomized to receive the study product, with 82 ultimately undergoing orthotopic liver transplantation.
The researchers found no significant differences in required red blood cell units between the placebo and recombinant factor VIIa study groups.
In addition, the team observed that the number of adverse events between the study groups was comparable.
Dr Emre's team stated, “Activated recombinant factor VII has a good safety profile in patients undergoing orthotopic liver transplantation.”
“However, the doses studied did not have any effect on the number of red blood cell transfusions required.”