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

NCT03849443 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 604

Last updated 2026-01-08

No results posted yet for this study

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.

Conditions

  • Open Posterior Thoracolumbar Spinal Fusion Procedure

Interventions

DRUG

Tranexamic Acid Injectable Product (1000 mg intravenous bolus)

Intravenous methods to decrease blood loss

DRUG

Vitamin C 250 MG Oral Tablet

Oral method of placebo

DRUG

Tranexamic Acid 650Mg Tablet

Oral method of treatment group

Sponsors & Collaborators

  • Rush University Medical Center

    lead OTHER

Principal Investigators

  • Bryce Basques, MD · Rush University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-26
Primary Completion
2026-12-01
Completion
2027-01-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03849443 on ClinicalTrials.gov