Actively Recruiting

Early Phase 1
Age: 18Years +
All Genders
NCT03849443

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

Led by Rush University Medical Center · Updated on 2026-01-08

604

Participants Needed

1

Research Sites

383 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient is older than 18 years old
  • Scheduled for an open posterior thoracolumbar spinal fusion procedure
Not Eligible

You will not qualify if you...

  • Allergy to tranexamic acid (TXA)
  • Acquired disturbances of color vision
  • Refusal of blood products
  • Use of anticoagulant therapy within five days before surgery
  • History of arterial or venous thromboembolic disease such as DVT, PE, CVA, or 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
  • Patient declines to participate
  • Intolerance or sensitivity to Vitamin C

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Rush University Medical Center

Chicago, Illinois, United States, 6060712

Actively Recruiting

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Research Team

M

Matthew Colman, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

4

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