Clinical Trial

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

Recruiting Early Phase 1
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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.
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2019-02-19; most recent amendment 2026-01-06.
Status change: Not Yet Recruiting → Recruiting 2019-09-11
Trial Details
NCT Number NCT03849443
Lead Sponsor Rush University Medical Center
Conditions Open Posterior Thoracolumbar Spinal Fusion Procedure
Enrollment 604 participants
Start Date 2019-08-26
Primary Completion 2026-12-01 (estimated)
Study Completion 2027-01-01 (estimated)
Updated on ClinicalTrials.gov 2026-01-08