Spine surgery breakthrough? simple drug pour may cut blood loss and transfusions
NCT ID NCT02314988
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether pouring tranexamic acid (TXA), a drug that helps blood clot, directly into the surgical wound during spine surgery can reduce bleeding and the need for blood transfusions. About 252 adults with spinal injuries or deformities will be randomly assigned to receive either TXA or a placebo (salt water) during their operation. Researchers will track blood loss, transfusion rates, and complications over two years.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- tranexamic acid (TXA)
- What this could lead to
- If it works, this could offer a simple, low-cost way to reduce blood loss and transfusion needs during spine surgery, potentially lowering infection risks.
- What could go wrong
- This is a mid-stage trial with 252 participants, so results may not apply to all patients. There is also a small risk of blood clots or other complications from the drug.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 252 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2020
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Thoracic or lumbar spinal column injury with or without neurologic deficit requiring surgical fixation 2. Surgical fixation to be performed within 21 days of injury 3. Adult patients undergoing long segment (\>5 fusion levels) posterior spinal fusions Exclusion Criteria: 1. Age \<18 or \>80 years old 2. Severe soft tissue disruption around planned surgical site preventing adequate primary wound closure 3. Physiologic instability or ongoing sepsis/infection 4. Use of intravenous tranexamic acid during the pre-study period 5. Ballistic spinal column injury 6. Allergy to tranexamic acid 7. Disturbances of color vision or color blindness 8. Pre-operative hemoglobin value of \<7 g/dL, or \<10 g/dL if patient has comorbidities or symptoms which will require pre-operative allogeneic blood transfusion 9. Refusal to consent for blood products 10. Participation in another clinical trial 11. Moderate or severe traumatic brain injuries that do not allow participation in individual patient outcomes surveys 12. Subarachnoid hemorrhage, anecdotal experience indicates that cerebral edema and cerebral infarction may be caused by TXA 13. Concomitant use of Factor IX Complex concentrates or Anti-inhibitor Coagulant concentrates, as the risk of thrombosis may be increased 14. Preoperative use of anticoagulant therapy (heparin, low-molecular weight heparin, warfarin) within three days before surgery, or non-steroid inflammatory medication (aspirin, ibuprofen, naprosyn) use within seven days before surgery 15. Fibrinolytic disorders requiring intraoperative antifibrinolytic treatment 16. Disseminated intravascular coagulation (DIC) 17. Coagulopathy (as identified by a preoperative platelet count of \<150,000/mm3, an international normalized ratio of \>1.4, or a prolonged partial thromboplastin time \>1.4 times normal) 18. History of arterial or venous thromboembolic disease (such as a cerebrovascular accident, deep-vein thrombosis, or pulmonary embolus), as these patients may be at increased risk for venous or arterial thrombosis 19. Upper urinary tract or ureteral injury (ureteral obstruction due to clot formation in patients with upper urinary tract bleeding has been reported) 20. Pregnancy or breastfeeding (Category B) 21. Substantial renal dysfunction (as assessed by a serum creatinine \> 1.5 or calculated creatinine clearance of \< 50) or hepatic failure 22. Major co-morbidities: alcohol or drug abuse, illnesses that affect bone or calcium metabolism, connective tissue disorders, coronary artery disease, severe ischemic heart disease \[New York Heart Association Class III or IV\], previous myocardial infarction, severe pulmonary disease \[forced expiratory volume \<50% of normal\], diabetes mellitus (Type I or Type II), immunosuppression, peripheral vascular disease, severe penetrating or hemorrhagic traumatic brain injury, a history of skeletal malignancies, prior external beam or implant radiation therapy involving the skeleton. 23. History of seizure or convulsive disorders, or currently concomitant use of other medications that are known to reduce seizure threshold 24. History of dural tear or open subdural space
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Duke University Medical Center
RECRUITINGDurham, North Carolina, 27710, United States
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NYP/The Allen Hospital - CUIMC
RECRUITINGNew York, New York, 10032, United States
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Norton Leatherman Spine Center
RECRUITINGLouisville, Kentucky, 40202, United States
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University of California San Francisco Medical Center
RECRUITINGSan Francisco, California, 94149, United States
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