Recombinant Activated Factor VIIa Combined With Tranexamic Acid Control Haemostasis in Patients With Severe Factor XI Deficiency Undergoing Urological Procedures

Introduction: Patients with severe Factor XI deficiency face unique challenges during urological procedures due to an elevated risk of bleeding, balanced against the use of tranexamic acid (TXA), which may form blood clots. Given the limitations associated with plasma-based treatment, there have been reports of successful and safe off-label use of recombinant activated Factor VII (rFVIIa) in combination with TXA in general surgery. Aim: Report our experience with this approach in urological surgeries involving tissues with heightened fibrinolytic activity. Methods: A retrospective case series analysed seven patients with severe FXI deficiency who underwent seven urological procedures. Five patients were classified as bleeders, and two developed antibodies to FXI following prior exposure to plasma. The use of off-label rFVIIa was approved by our institutional authorities. Patients received TXA 1 g four times daily for 7–10 days, and a single dose of 10–15 mcg/kg of rFVIIa at the end of surgery (based on previous thrombin generation studies). Patients were connected to a continuous irrigation system postoperatively and monitored for urinary bleeding. Results: All procedures were performed without significant bleeding complications, except for one patient who remained on aspirin therapy and experienced manageable bleeding. None of the patients required discontinuation of TXA due to blood clots, nor did they require blood transfusions or additional doses of rFVIIa. No thrombotic complications were observed. Conclusion: Combination of low-dose rFVIIa with TXA is a feasible and attractive option for patients undergoing urologic procedures. Further implications of this protocol should be implemented in clinical practice.