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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Any patient older than 18 years old

• Scheduled for an open posterior thoracolumbar spinal fusion procedure

Locations
United States
Illinois
Rush University Medical Center
RECRUITING
Chicago
Contact Information
Primary
Matthew Colman, MD
an.research@rushortho.com
312-432-2468
Time Frame
Start Date: 2019-08-26
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 604
Treatments
Placebo_comparator: Group 1 PLACEBO
Experimental: Group 2 IV TXA
Experimental: Group 3 Pre-Oral TXA
Experimental: Group 4 Full Oral TXA
Related Therapeutic Areas
Sponsors
Leads: Rush University Medical Center

This content was sourced from clinicaltrials.gov