Recombinant Factor Vila for Haemostatic Management of Patients Undergoing Craniosynostosis Surgery: A Double-Blind, Placebo-Controlled Study

Background: Several strategies have been used to compensate for blood loss in craniosynostosis surgery. In addition to conventional blood component transfusion, preoperative autologous blood transfusion, induced hypotension and administration of recombinant human erythropoietin as well as fibrinogen have all been tried. The use of recombinant factor Vila has been reported in children undergoing major neurosurgical procedures and experiencing massive uncontrolled hemorrhagic shock. Moreover, in the last few years the indications for using recombinant factor Vila were broadened and its use was started as a preventive measure rather than as a last line of defense.Objectives: The aim of this study is to evaluate the effectiveness of using recombinant factor Vila for reduction of blood loss and blood component transfusion in patients undergoing craniosynostosis surgery.Methods: This is a prospective, randomized, placebo- controlled study performed on 40 patients undergoing craniosynostosis surgery. Patients were randomized to groups A and B. Group A received 90microgram/kilogram recombinant factor Vila 10 minutes after the start of surgery. Group B received the same volume of saline at the same time interval. Blood loss, transfusion requirements as well as coagulation tests (prothrombin time and partial thromboplastin time) were assessed in both groups.Results: Blood loss was reduced by 47.7% and packed red cell transfusion was reduced by approximately 59% in the group which received rFVIIa compared to the control group. In group B (placebo): Fibrinogen was significantly reduced while prothrombin time and partial thromboplastin time were significantly prolonged compared to group A which received recombinant factor Vila.Conclusion: In the present study, 90microgram/kilogram of recombinant factor Vila given prophylactically to 20 pediatric patients undergoing sagittal craniosynostosis was effective in reducing the amount of blood loss and red cell transfusion without adverse thromboembolic events.