TXA in Spinal Fusion (NCT04272606) | Clinical Trial Compass
CompletedPhase 2
TXA in Spinal Fusion
United States123 participantsStarted 2020-08-01
Plain-language summary
Tranexamic acid and placebo will be given during surgery to patients who have elected to undergo lumber interbody fusion on 2 or more levels. Information regarding blood loss, transfusions needed, postoperative cognitive status (including delirium), postoperative markers of systemic inflammation and duration of hospital stay will be collected.
Who can participate
Age range
18 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 18-90 years
. American Spinal Injury Association (ASA) Impairment Scale anesthesia risk of I to IV
. Patients undergoing 2 or more levels of posterior lumbar interbody fusion for DDD. This includes PLIF or TLIF.
. Patients have failed conservative management, which include physical therapy (PT) or occupational therapy (OT) and/or injections.
Exclusion criteria
. ASA class V
. Patient unable to consent
. Patient with chronic kidney disease stage III or above: baseline plasma creatinine\>1.5mg/dL
. Patient with known liver failure
. Patients on anticoagulation or dual antiplatelets (presence of vascular stents).
. Patients with artificial valves.
. Patients with allergy to TXA
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Transfusion
Timeframe: Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported
2
Blood Loss
Timeframe: Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported
3
Delirium Occurrence
Timeframe: Assessed up to 5 days or until discharge, whichever came first, data collected on discharge day or day 5 reported