drugset / Trial / NCT03849443

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

NCT03849443

Phase 0 Recruiting 604 enrolled Rush University Medical Center
RandomizedParallel-groupQuadruple-blindPrevention

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.

Timeline

Start
2019-08-26
Primary completion
2026-12-01
Completion
2027-01-01

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Tranexamic Acid Small molecule 1000 mg Intravenous
Subject Tranexamic Acid Small molecule 1875 mg Oral

Indications

No indication recorded.