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

RecruitingEARLY Phase 1Ages 18 Years - anyAllRush University Medical Center
NCT03849443 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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 * Patients who decline to participate * Intolerance or sensitivity to Vitamin C
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What it tests

  • Tranexamic Acid Injectable Product (1000 mg intravenous bolus)
  • Vitamin C 250 MG Oral Tablet
  • Tranexamic Acid 650Mg Tablet
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Where

1 site
Rush University Medical Center
Chicago, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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