Tranexamic Acid to Reduce Blood Loss in Spine Surgery

Launched by COLUMBIA UNIVERSITY · Dec 8, 2014

Keywords

ClinConnect Summary

This clinical trial is investigating whether a medication called tranexamic acid can help reduce blood loss during and after spine surgery for patients with serious spinal injuries or deformities. The study will involve adults who need surgery for injuries to their thoracic or lumbar spine, particularly those who have fractures or dislocations from high-energy trauma, as well as patients undergoing complex elective surgeries. Participants will be randomly assigned to receive either tranexamic acid or a placebo (a harmless solution) during their surgery, and the study aims to see if the medication leads to less blood loss and fewer blood transfusions.

To be eligible for this trial, patients must be between 18 and 80 years old and need surgical fixation for their spinal injury within 21 days of the injury. They should be able to undergo a long segment spinal fusion, which is a type of surgery that stabilizes multiple levels of the spine. Participants will be followed for two years after their surgery, with check-ups at various points to gather information about their recovery. It's important to know that some individuals, such as those with certain medical conditions or taking specific medications, may not qualify for this study. If you or a loved one are considering participation, the research team can provide more details to help you understand the process and any potential risks involved.

Gender

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Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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