Tranexamic Acid to Reduce Blood Loss in Spine Surgery

Eligibility Criteria

• 1. Thoracic or lumbar spinal column injury with or without neurologic deficit requiring surgical fixation
• 2. Surgical fixation to be performed within 21 days of injury
• 3. Adult patients undergoing long segment (\>5 fusion levels) posterior spinal fusions
• 1. Age \<18 or \>80 years old
• 2. Severe soft tissue disruption around planned surgical site preventing adequate primary wound closure
• 3. Physiologic instability or ongoing sepsis/infection
• 4. Use of intravenous tranexamic acid during the pre-study period
• 5. Ballistic spinal column injury
• 6. Allergy to tranexamic acid
• 7. Disturbances of color vision or color blindness
• 8. Pre-operative hemoglobin value of \<7 g/dL, or \<10 g/dL if patient has comorbidities or symptoms which will require pre-operative allogeneic blood transfusion
• 9. Refusal to consent for blood products
• 10. Participation in another clinical trial
• 11. Moderate or severe traumatic brain injuries that do not allow participation in individual patient outcomes surveys
• 12. Subarachnoid hemorrhage, anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by TXA
• 13. Concomitant use of Factor IX Complex concentrates or Anti-inhibitor Coagulant concentrates, as the risk of thrombosis may be increased
• 14. Preoperative use of anticoagulant therapy (heparin, low-molecular weight heparin, warfarin) within three days before surgery, or non-steroid inflammatory medication (aspirin, ibuprofen, naprosyn) use within seven days before surgery
• 15. Fibrinolytic disorders requiring intraoperative antifibrinolytic treatment
• 16. Disseminated intravascular coagulation (DIC)
• 17. Coagulopathy (as identified by a preoperative platelet count of \<150,000/mm3, an international normalized ratio of \>1.4, or a prolonged partial thromboplastin time \>1.4 times normal)
• 18. History of arterial or venous thromboembolic disease (such as a cerebrovascular accident, deep-vein thrombosis, or pulmonary embolus), as these patients may be at increased risk for venous or arterial thrombosis
• 19. Upper urinary tract or ureteral injury (ureteral obstruction due to clot formation in patients with upper urinary tract bleeding has been reported)
• 20. Pregnancy or breastfeeding (Category B)
• 21. Substantial renal dysfunction (as assessed by a serum creatinine \> 1.5 or calculated creatinine clearance of \< 50) or hepatic failure
• 22. Major co-morbidities: alcohol or drug abuse, illnesses that affect bone or calcium metabolism, connective tissue disorders, coronary artery disease, severe ischemic heart disease \[New York Heart Association Class III or IV\], previous myocardial infarction, severe pulmonary disease \[forced expiratory volume \<50% of normal\], diabetes mellitus (Type I or Type II), immunosuppression, peripheral vascular disease, severe penetrating or hemorrhagic traumatic brain injury, a history of skeletal malignancies, prior external beam or implant radiation therapy involving the skeleton.
• 23. History of seizure or convulsive disorders, or currently concomitant use of other medications that are known to reduce seizure threshold
• 24. History of dural tear or open subdural space