Single Versus Multi-Dose Oral and Intravenous Tranexamic Acid in Patients at High Risk for Blood Transfusion After Spine Surgery
Rush University Medical Center
Summary
As tranexamic acid (TXA) becomes more prevalent, all patients are receiving the same dose and method of delivery regardless of their pre-operative risk of transfusion. Therefore, the aim of the study is to determine whether or not repeated dosing of oral or different method of delivery like intravenous (IV) TXA reduces the postoperative reduction in hemoglobin, hematocrit, number of transfusions, and postoperative blood loss following open spine surgery. The regimen that utilizes multiple doses of oral TXA will significantly minimize post-operative blood loss and transfusion requirements compared to the use of a single dose regimen. Furthermore, oral TXA will be as efficacious as intravenous delivery of TXA.
Description
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…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Any patient older than 18 years old * 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 * History of arterial or venous thromboembolic disease (such as DVT, PE, CVA, TIA) * Pregnancy * Breastfeeding * Severe ischemic heart disease \[New York Heart Association Class III or IV\] * Previous myocardial infarction * Severe pulmonary disease * Renal impairment * Hepatic failure * Pat…
Interventions
- DrugTranexamic Acid Injectable Product (1000 mg intravenous bolus)
Intravenous methods to decrease blood loss
- DrugVitamin C 250 MG Oral Tablet
Oral method of placebo
- DrugTranexamic Acid 650Mg Tablet
Oral method of treatment group
Location
- Rush University Medical CenterChicago, Illinois