NCT03553186 · Hospital for Special Surgery, New York
Tranexamic Acid in Adult Spinal Deformity Surgery
What this study is about
Posterior spinal surgery for adult deformity is associated with high incidence of blood loss and need for blood transfusion and intraoperative blood salvage, with associated increased cost and risk for perioperative complications.
View original scientific description
Posterior spinal surgery for adult deformity is associated with high incidence of blood loss and need for blood transfusion and intraoperative blood salvage, with associated increased cost and risk for perioperative complications. Tranexamic acid (TXA) is relatively inexpensive anti-fibrinolytic agent that has been proven effective for decreasing intraoperative blood loss in various surgical specialties. Intravenous TXA (ivTXA) is routinely used at our institution for adult spinal deformity cases. Meanwhile, topical TXA (tTXA) is an attractive alternative/adjunct to ivTXA used with good results in orthopedic arthroplasty and cardiac surgery. To the investigators' knowledge, no data exists in the literature on the use of tTXA in either adult or pediatric spinal deformity surgery. The goal of this study is to determine the role tTXA has an adjunct to ivTXA in decreasing perioperative blood loss, drainage, transfusion requirements and length of stay following adult deformity spine 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
- Scheduled to undergo posterior long segment ( ≥ 5 levels) posterior spinal fusion for adult scoliosis or degenerative joint diseae
- \+ fusion to pelvis
Exclusion criteria
- Surgical factors:
- Anterior Approach
- Presence or history of dural tear without repair as evidenced by pseudomeningocele on MRI imaging or by intraoperative exploration
- Patients donating autologous blood preoperatively Patient factors:
- Diagnosis of renal (Cr\>1.5 or CrCl \<30ml/min) or hepatic insufficiency (AST, ALT 2x upper limit of normal)
- Diagnosis of seizure disorder or prior seizure
- History of thromboembolic events (CVA, TIA, DVT, PE) if within 1 year of surgery
- Hypercoagulability (e.g. antiphospholipid syndrome)
- History of coronary artery disease (stent, MI, +stress test) within 1 year of surgery
- Atrial fibrillation
- Concurrent anticoagulation therapy that cannot be discontinued within 3 days before surgery (Coumadin, plavix, LVX)
- Concurrent anticoagulation with ASA 325 that cannot be discontinued 10 days before surgery
- Bleeding disorder or abnormal preoperative coagulation profile (as identified by a preoperative platelet count of \<100,000/mm3, an international normalized ratio of \>1.4, or a prolonged partial thromboplastin time \>1.4 times normal)
- Preexisting anemia \<10 g/dL
- Color blindness or disturbance of color vision
- Leukemia or active cancer
- Religious restrictions on blood transfusion
- Pregnancy or women who are lactating/breastfeeding
Where
- New York, New York
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 Apr 28, 2026 · Source of record for eligibility and locations