Comparing two doses of intraoperative tranexamic acid on blood loss, blood and blood product transfusion requirements in patients undergoing complex skull base tumour resection: A non-inferiority randomized control trial

Skull base tumour resection is associated with major blood loss and an increased risk for perioperative allogenic transfusion. Perioperative blood and blood product transfusions are associated with increased morbidity and mortality. Various perioperative blood-conservation strategies are routinely used to reduce the allogenic blood transfusion in patients undergoing complex brain tumour surgery. TXA is one of the crucial components of perioperative blood conservation strategies.

Tranexamic acid (TXA), is a synthetic lysine analogue that prevents activation of plasminogen into plasmin. TXA functions as an antifibrinolytic by preventing the plasmin-induced fibrinolysis and stabilising the existing clot. TXA has been shown to reduce bleeding in various surgical conditions, including neurosurgery.  Among the neurosurgical procedures, its use has been well documented for reducing the blood loss and blood transfusion in traumatic brain injury, major spine surgery, craniosynostosis correction surgery and meningioma surgeries. But its use in other elective craniotomies, such as complex skull base tumours, is understudied.

Based on a thorough literature search, to our knowledge, to date, there is only one retrospective study which looked at the effect of TXA on blood loss and blood transfusion requirement in patients undergoing skull base tumour excision. Hence, we wanted to do an RCT in all adult patients undergoing complex skull base tumours and study the efficacy of TXA on reducing the blood loss during surgery and blood transfusion during and within 6 hours of transfusion .

All eligible patients will be approached and recruited into the study after obtaining informed consent. Then they will be randomized to either Group A (20mg/kg bolus f/b 2 mg/kg/hr infusion, intermediate dose) or Group B (10mg/kg bolus f/b 1 mg/kg/hr infusion, low-dose) according to the randomisation sequence. TXA infusion will be continued till dural closure. Standard anaesthesia protocol will be followed for induction, intubation and maintenance. Intraoperative fluid administration will be guided by Pulse pressure variation, haemodynamics (MAP and HR), and urine output.  Blood loss will be calculated in a standardised manner. All the necessary pre- and intraoperative data will be collected. Blood and blood products will be transfused based on the definite transfusion trigger. Serum samples for TXA level and ROTEM(Modified EXTEM) will be taken 1 hour after stopping the TXA infusion. At the end of surgery, patients will be extubated (after meeting the extubation criteria) or ventilated, depending on the intraoperative course at the discretion of the anaesthesiologist or surgeon. Postoperatively, patients will be followed up till discharge the necessary data will be calculated and documented in the data sheet.