A Randomized Double-Blind Study Evaluating Fibrinogen-Tranexamic Acid Preventive Therapy Versus a Combined Low-Dose Regimen on Surgical Bleeding Management and Critical Care Outcomes in Patients Undergoing Radical Cystectomy

Background: Radical cystectomy (RC) remains the standard of care for high-risk bladder cancer despite being associated with elevated perioperative morbidity. The procedure commonly results in substantial intraoperative blood loss, frequently requiring perioperative blood transfusions (PBT), which are associated with adverse events including transfusion-related complications and heightened healthcare expenditures. Pharmacological interventions such as tranexamic acid (TXA) and fibrinogen may decrease transfusion requirements, though TXA's potential thrombogenic effects raise safety concerns. This randomized controlled trial (RCT) aims to investigate the efficacy of combined fibrinogen and TXA delivery protocol in minimizing surgical blood loss and enhancing postoperative recovery in RC patients. Methods: This randomized controlled trial (RCT) enrolled 140 participants scheduled for elective radical cystectomy (RC) procedures. Eligible individuals were randomly allocated to four study arms: one administered fibrinogen concentrate, a second receiving tranexamic acid (TXA), a third assigned to a lower-dose combination of both agents, and a control group receiving placebo. Primary outcomes evaluated perioperative blood loss (intraoperative and postoperative), while secondary outcomes encompased vital physiological markers and the incidence of postoperative adverse events. Results: Patients administered fibrinogen, TXA, or a combination of both demonstrated a marked decrease in postoperative hemorrhage (1,437–1,463 mL vs. 2,727 mL in controls). Furthermore, surgical timeframes showed significant contraction in the intervention groups (4.76–4.79 hours) compared to controls (5.58 hours). These treatments were also associated with shorter hospital stays and reduced transfusion volumes of packed red blood cells and fresh frozen plasma (FFP). No statistically significant variations in acidosis or hemoglobin concentrations were observed across groups. Conversely, fibrinogen and TXA delivery protocol substantially elevated fibrinogen levels, though no clinically relevant differences emerged between the intervention patient groups. Conclusion: The trial demonstrates that adjusting fibrinogen and TXA dosage protocols effectively reduces surgical bleeding during radical cystectomy. While combination therapy showed comparable efficacy to individual agents, these pharmacological strategies decreased transfusion dependency and hospitalization duration without increasing thromboembolic risks.