The Administration of FVIIa in Children for Bleeding of Nonhemophilic Causes: Does it Decrease Bleeding: A Randomized Controlled Trial

Objective: To evaluate the efficacy of rFVIIa in reducing blood loss during pediatric brain surgery by Thromboelastography. Design: Randomised controlled trial. Participants and Methods: Patients were randomly allocated into one of three groups: Group I: Received the conventional treatment of bleeding i.e. blood products e.g. RBCs, plasma and platelets. Group II: Given in a dose of 30ug.kg^–1 (Novoseven® after the induction of anesthesia Group III: rFVIIa was given in a dose of 60ug.kg^– 1 as IV bolus. To assess the efficacy of rFVIIa, different variables were monitored: Amount of blood loss in each patient, effect on hematological parameters, e.g. aPTT, INR, Plt and fibrinogen, quantity of blood products used intraoperatively then Thromboelastogram was evaluated. Results: There were statistically significant differences between the three groups regarding blood loss, where mean (±SD) of intraoperative blood loss was 450.00ml (±251.425) in the control group, 184.67ml (±192.627) in rFVIIa 30mg group and 101.67ml (±72.744) in rFVIIa 60mg group, (p= 0.000). Regarding Thromboelastogram, there were statistically significant differences between the three groups regarding R time, K time, MA and a-angle at R1, K1, MA1, and a1, as p 0.05. Conclusion: The administration of rFVIIa in children for bleeding of nonhemophilic causes is associated with a dose dependent reduction in laboratory bleeding indices and does not appear to result in thrombotic events.