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RECRUITING
NCT03849443
EARLY_PHASE1

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

Sponsor: Rush University Medical Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

604

Start Date

2019-08-26

Completion Date

2027-01-01

Last Updated

2026-01-08

Healthy Volunteers

No

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

Locations (1)

Rush University Medical Center

Chicago, Illinois, United States