← Back to Clinical Trials
RecruitingEARLY_Phase 1NCT03849443

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

◆ AI Clinical Summary
Plain-language summary for patients

Trial Parameters

ConditionOpen Posterior Thoracolumbar Spinal Fusion Procedure
SponsorRush University Medical Center
Study TypeINTERVENTIONAL
PhaseEARLY_Phase 1
Enrollment604
SexALL
Min Age18 Years
Max AgeN/A
Start Date2019-08-26
Completion2026-12-01
Interventions
Tranexamic Acid Injectable Product (1000 mg intravenous bolus)Vitamin C 250 MG Oral TabletTranexamic Acid 650Mg Tablet

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

Brief 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.

Eligibility 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

Related Trials