NCT03849443 · Rush University Medical Center
Single Versus Multi-Dose Oral and Intravenous Tranexamic Acid Patients at High Risk for Blood Transfusion After Spine Surgery
What this study 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.
View original scientific description
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.
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
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
- 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
Where
- Chicago, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 8, 2026 · Source of record for eligibility and locations