Tranexamic Acid to Reduce Blood Loss in Spine Trauma Surgery

Open to people ages 18-80

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