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Compares treatment options for Open Posterior Thoracolumbar Spinal Fusion Procedure
Official title Single Versus Multi-Dose Oral and Intravenous Tranexamic Acid Patients at High Risk for Blood Transfusion After Spine Surgery
ClinicalTrials.gov ID: NCT03849443
What this study is testing
What is Tranexamic Acid Injectable Product (1000 mg intravenous bolus)?
Tranexamic Acid Injectable Product (1000 mg intravenous bolus) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for open posterior thoracolumbar spinal fusion procedure.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Any patient older than 18 years old
- Scheduled for an open posterior thoracolumbar spinal fusion procedure
You likely can't join if
- 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
See the full eligibility criteria
- Any patient older than 18 years old
- Scheduled for an open posterior thoracolumbar spinal fusion procedure
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Chicago, Illinois, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chicago, Illinois, United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.