Recruiting
Early Phase 1

Tranexamic Acid vs. Multi-Dose

Sponsor:

Rush University Medical Center

Code:

NCT03849443

Conditions

Open Posterior Thoracolumbar Spinal Fusion Procedure

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Tranexamic Acid Injectable Product (1000 mg intravenous bolus)

Vitamin C 250 MG Oral Tablet

Tranexamic Acid 650Mg Tablet

Study Details

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.

Conditions

Open Posterior Thoracolumbar Spinal Fusion Procedure

Study ID

NCT03849443

Start date

Aug 26, 2019

Status verified date

Jan, 2026

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

604 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

placebo comparator: Group 1 PLACEBO

experimental: Group 2 IV TXA

experimental: Group 3 Pre-Oral TXA

experimental: Group 4 Full Oral TXA

Interventions

Tranexamic Acid Injectable Product (1000 mg intravenous bolus)

Intravenous methods to decrease blood loss

Vitamin C 250 MG Oral Tablet

Oral method of placebo

Tranexamic Acid 650Mg Tablet

Oral method of treatment group

Primary outcome measure

  • Postoperative blood loss [ Time Frame: During hospital stay and at routine outpatient follow-up visit which occurs about 3 weeks after discharge and within 30 days of surgery ]

Central Contacts and Locations

Central contacts

Matthew Colman, MD

312-432-2468an.research@rushortho.com

Locations

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 6060712

Contacts

Matthew Colman, MD

312-432-2468an.research@rushortho.com

More Information

Sponsor

Rush University Medical Center

Last update posted

Jan 8, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rush University Medical Center on 2026-01-08.