Tranexamic acid (Cyklokapron®) applied in the wound to reduce blood loss during spine surgery

You may qualify if

• Thoracic or lumbar spinal column injury with or without neurologic deficit requiring surgical fixation
• Surgical fixation to be performed within 21 days of injury
• Adult patients undergoing long segment (>5 fusion levels) posterior spinal fusions

You can't join if

• Age <18 or >80 years old
• Severe soft tissue disruption around planned surgical site preventing adequate primary wound closure
• Physiologic instability or ongoing sepsis/infection
• Use of intravenous tranexamic acid during the pre-study period
• Ballistic spinal column injury
• Allergy to tranexamic acid
• Disturbances of color vision or color blindness
• 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
• Refusal to consent for blood products
• Participation in another clinical trial
• Moderate or severe traumatic brain injuries that do not allow participation in individual patient outcomes surveys
• Subarachnoid hemorrhage, anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by TXA
• Concomitant use of Factor IX Complex concentrates or Anti-inhibitor Coagulant concentrates, as the risk of thrombosis may be increased
• 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
• Fibrinolytic disorders requiring intraoperative antifibrinolytic treatment
• Disseminated intravascular coagulation (DIC)
• 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)
• 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
• Upper urinary tract or ureteral injury (ureteral obstruction due to clot formation in patients with upper urinary tract bleeding has been reported)
• Pregnancy or breastfeeding (Category B)
• Substantial renal dysfunction (as assessed by a serum creatinine > 1.5 or calculated creatinine clearance of < 50) or hepatic failure
• 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.
• History of seizure or convulsive disorders, or currently concomitant use of other medications that are known to reduce seizure threshold
• History of dural tear or open subdural space