Clinical experience with simoctocog alfa in surgical management of patients with severe hemophilia A

Abstract

Summary. Introduction. Surgical interventions in patients with severe hemophilia A are associated with a high risk of massive bleeding. Achieving and maintaining adequate levels of coagulation factor VIII (FVIII) is a crucial prerequisite for successful surgical outcomes. The recombinant product simoctocog alfa has demonstrated efficacy and a favorable safety profile in international clinical trials. To date, real- world experience with its use in surgical practice has been accumulated at our center. Aim: to assess the efficacy and safety of simoctocog alfa in patients with severe hemophilia A undergoing surgical procedures in real-world clinical practice. Materials and Methods. A retro- spective analysis included 26 patients (aged 21–66 years) who underwent 35 surgical procedures (25 major and 10 minor) with replacement therapy using simoctocog alfa. All patients underwent standard preoperative and postoperative evaluations according to our departmental protocol. Laboratory monitoring included coagulation profiles, FVIII activity, and routine clinical and biochemical blood tests preoperatively, as well as 12 and 24 hours after surgery. Intraoperative blood loss, need for blood transfusions, and complications were recorded. Statistical analysis was performed using the paired t-test. Results. The median intraoperative blood loss was 275 ml (range: 30–1250 ml). Significant blood loss in 3 patients was due to technical difficulties. In all other cases, intraoperative blood loss did not exceed the expected value. In four cases (11.4%), blood transfusions were required. No allergic reactions, thrombotic complications, or other adverse events were observed. No inhibitors to FVIII were detected in any patient during the perioperative period. Conclusion. The analysis of simoctocog alfa use in routine surgical practice demonstrated its efficacy and safety in both major and minor orthopedic procedures in patients with severe hemophilia A. These findings are consistent with data from international clinical studies.

For citation: Zorenko V.Yu., Polyanskaya T.Yu., Karpov E.E., Koroleva A.A. Clinical experience with simoctocog alfa in surgical management of patients with severe hemophilia A. Tromboz, gemostaz i reologiya. 2025;(4):69–75. (In Russ.).

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