Single Versus Multi-Dose Oral and Intravenous Tranexamic Acid in Patients at High Risk for Blood Transfusion After Spine Surgery

Background/Scientific review:

Open lumbar spine surgery is associated with the risk of moderate to significant blood loss. Because TXA has been shown to significantly reduce the need for blood products during total joint replacement, it is now the standard of care for these procedures at many institutions.1-3 Oral and IV TXA have been found to be similarly efficacious in total joint replacements, but oral TXA is cheaper and allows for ease of repeat dosing.1 Although low preoperative hemoglobin is a risk factor for transfusion, no studies that have compared standard single-dose oral or IV TXA dosing to repeated oral dosing of TXA in patients undergoing open spine surgery.

Study Design: Prospective, randomized, double-blinded study Inclusion Criteria: Any patient older than 18 years old and scheduled for an open posterior thoracolumbar spinal fusion procedure

Exclusion Criteria: Allergy to TXA, acquired disturbances of color vision, refusal of blood products, pre-op use of anticoagulant therapy within five days before surgery, a history of arterial or venous thromboembolic disease (such as DVT, PE, CVA, TIA), pregnancy, breastfeeding, major comorbidities (such as severe ischemic heart disease [New York Heart Association Class III or IV], previous myocardial infarction, severe pulmonary disease, renal impairment, or hepatic failure), patients who decline to participate, intolerance or sensitivity to Vitamin C.

Screening Procedures and Randomization: At the pre-operative clinic appointment and before the day of surgery, the study staff will assess the potential subject's eligibility, which would include asking for any intolerance/sensitivity to Vitamin C. Once eligibility is established, the potential subject will be approached regarding their participation in this clinical trial. The investigators will provide 48 hours before the date of surgery to allot for questions and consideration of the Informed Consent document. Once all patient questions have been answered patients willing to be in the study will sign the Informed Consent. Patients will be randomized, via standard randomization tables that provide a 1:1:1:1 distribution of subjects between the four groups through blocked randomization, no later than the morning of surgery to either of the four treatment groups: Placebo, Preoperative IV TXA, Preoperative-oral TXA only, or Full (pre-op and post-op) Oral TXA.