Comparing single and multiple doses of tranexamic acid for spine surgery patients
Official title: Single Versus Multi-Dose Oral and Intravenous Tranexamic Acid in Patients at High Risk for Blood Transfusion After Spine Surgery
Run by Rush University Medical Center · NCT03849443 · Data updated 2026-11-12
This study is testing whether giving one or multiple doses of tranexamic acid can help reduce blood loss and the need for blood transfusions in patients having spine surgery.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 604 (estimated) |
| Sponsor | Rush University Medical Center Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Status | Recruiting |
| Started | August 26, 2019 |
| Main results expected | December 1, 2026 |
| Study ends | January 1, 2027 |
| Registry record updated | January 8, 2026 |
| Trial ID | NCT03849443 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults over 18 scheduled for open posterior thoracolumbar spinal fusion surgery.
✕Probably not a fit
Patients with a history of thromboembolic disease, severe comorbidities, or those who refuse blood products may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate the effectiveness of single versus multiple doses of tranexamic acid (TXA) in reducing blood loss and the need for transfusions in patients undergoing open posterior thoracolumbar spinal fusion surgery. It will compare the outcomes of patients receiving a single dose of TXA with those receiving repeated oral doses or intravenous administration. The study is designed as a prospective, randomized, double-blinded trial, ensuring that neither the participants nor the researchers know which treatment is being administered. The goal is to determine if a multi-dose regimen can significantly minimize postoperative complications related to blood loss.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative outcomes and reduced transfusion needs for patients undergoing spine surgery.
How similar studies have gone: Previous studies have shown that tranexamic acid can effectively reduce blood loss in other surgical procedures, suggesting potential success for this approach in spine surgery.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Rush University Medical Center
Chicago, Illinois, United States Recruiting
Study contacts
- Principal investigator: Bryce Basques, MD — Rush University Medical Center
- Study coordinator: Matthew Colman, MD
- Email: an.research@rushortho.com
- Phone: 312-432-2468
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.