Effect of activated recombinant factor VII versus tranexamic acid infusion on bleeding during spine surgery, randomized, controlled, double blinded trial

Background
Antifibrinolytic drugs, such as tranexamic acid are medications that facilitate hemostasis and decrease blood loss and the need for blood transfusion during major surgery. Activated recombinant coagulation factor VII is a novel hemostatic agent, studies revealed that it is helpful hemostatic in disorders with impaired hemostasis, as well as in patients with normal hemostatic function to minimize perioperative blood loss. This study aimed to compare the efficacy of activated recombinant factor VII with tranexamic acid in reducing the perioperative blood loss.
Methods
50 patients undergoing spine surgery were enrolled in this study. Group A patients were given activated recombinant factor VII and group T patients given tranexamic acid. In both groups, anesthesia was induced using fentanyl 3 μg/kg and propofol 2 mg/kg; muscle relaxation was initiated using cisatracurium 0.2 mg/kg. Transfusion of blood and its products was done according to a value guide. The primary outcome variable of the study was the total volume of blood loss in the perioperative period. Secondary outcome variables include perioperative transfusion requirement, and the number of patients who needed transfusion, as well as time of operation. A -value less than 0.05 is considered statistically significant.
Results
The current study showed that the total perioperative blood loss in group A was significantly lower than group T. None of the patients required ICU admission, as well as reentry to operating theater. Furthermore, no significant difference was detected in the number of patients needed blood transfusion. Intraoperative bleeding was associated with a slight decrease of hemoglobin in group A.
Conclusion
The present study concluded that administration of activated recombinant factor VII in spine surgery reduces the total perioperative blood loss and the total volume of intraoperative blood transfusion compared with tranexamic acid, with no evidence of adverse effects.