Multilevel spinal stabilization surgery is frequently associated with substantial blood loss and increased transfusion requirements. Tranexamic acid (TXA), an antifibrinolytic agent, reduces perioperative bleeding, but the optimal intravenous dosing regimen remains controversial. This study aimed to compare the efficacy and safety of two TXA dosing protocols in patients undergoing ≥3-level spinal stabilization surgery.
Multilevel spinal stabilization surgery is frequently associated with substantial blood loss and increased transfusion requirements. Tranexamic acid (TXA), an antifibrinolytic agent, reduces perioperative bleeding, but the optimal intravenous dosing regimen remains controversial. This study aimed to compare the efficacy and safety of two TXA dosing protocols in patients undergoing ≥3-level spinal stabilization surgery.In this prospective, randomized trial, 62 adult patients scheduled for elective thoracolumbar stabilization involving three or more levels were assigned to receive either low-dose TXA (n= 31): 5 mg/kg loading + 1 mg/kg/h infusion or high-dose TXA (n = 31): 10 mg/kg loading +2 mg/kg/h infusion.TXA was administered intravenously 15 minutes before incision. Intraoperative blood loss, transfusion requirements, perioperative laboratory values, and complications (thromboembolic, neurological, renal, allergic, and seizure-related) were recorded. Patients were monitored for 48 hours postoperatively.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
62
low-dose TXA (n= 31): 5 mg/kg loading + 1 mg/kg/h infusion
high-dose TXA (n = 31): 10 mg/kg loading +2 mg/kg/h infusion
Kartal Dr. Lütfi Kırdar Şehir Hastanesi
Istanbul, Turkey (Türkiye)
Intraoperative Blood Loss [Milliliters]
The total amount of blood lost during surgery, measured in milliliters.
Time frame: During the operation
Number of Patients Requiring Intraoperative Erythrocyte Suspension Transfusion [Number of Participants]
Number of participants who required intraoperative erythrocyte suspension (ES) transfusion.
Time frame: During the operation
Postoperative Hemoglobin Level at 24 and 48 Hours [g/dL]
Hemoglobin values measured at 24 and 48 hours after surgery.
Time frame: 24 and 48 hours postoperatively
Postoperative Hematocrit Level at 24 and 48 Hours [Percent (%)]
Hematocrit levels measured at 24 and 48 hours after surgery.
Time frame: 24 and 48 hours postoperatively
Postoperative Platelet Count at 24 and 48 Hours [×10⁹/L or per mm³]
Platelet count measured at 24 and 48 hours after surgery.
Time frame: 24 and 48 hours postoperatively
Aspartate Aminotransferase (AST) Level at 24 and 48 Hours [U/L]
Biochemical Parameters
Time frame: 24 and 48 hours postoperatively
Alanine Aminotransferase (ALT) Level at 24 and 48 Hours [U/L]
Biochemical Parameters
Time frame: 24 and 48 hours postoperatively
Blood Urea Nitrogen (BUN) Level at 24 and 48 Hours [mg/dL]
Biochemical Parameters
Time frame: 24 and 48 hours postoperatively
Creatinine Level at 24 and 48 Hours [mg/dL]
Biochemical Parameters
Time frame: 24 and 48 hours postoperatively
Incidence of Postoperative Nausea and Vomiting [Number of Participants]
Number of participants experiencing nausea and vomiting within 48 hours after surgery, potentially related to tranexamic acid (TXA) administration.
Time frame: First 48 hours postoperatively
Incidence of Serious Adverse Events Related to Tranexamic Acid [Number of Participants]
Number of participants experiencing serious adverse events attributable to tranexamic acid use.
Time frame: First 48 hours postoperatively
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