Multicenter, Randomized Placebo-controlled Clinical Trial to Evaluate the Effect of Perioperative Use of Tranexamic Acid on Transfusion Requirements and Surgical Bleeding in Major Spine Surgery

Inclusion Criteria:

• Patients ≥18 years old of both sexes
• scheduled for complex spine surgery
• ASA I-III
• weighing more than 30 kg
• body mass index <30 kg/m2
• operated on in the participating hospitals
• major spinal surgery
• signed an informed consent form to be included in the study

Exclusion Criteria:

• a history of allergy or hypersensitivity to the agent used
• receiving medication that can interfere with coagulation (acetylsalicylic acid, oral anticoagulants, or antiplatelet agents)
• a history of frequent bleeding
• plasma creatinine values >1.5 mg/dL in the baseline analysis
• platelet count less than 150,000/mm3 in the follow-up analysis
• abnormal prothrombin time (INR >1.5) or partial thromboplastin time (INR >1.5)
• a history of a thromboembolic episode before surgery
• family history of thromboembolism
• lack of consent to participate in the study
• infectious disease, tumor or trauma of the spine as the reason for surgery
• scheduled for surgery with an anterior and posterior surgical approach, whether sequential or on the same day