Actively Recruiting
Topical Tranexamic Acid as an Adjunct to Intravenous Tranexamic Acid in Adult Spinal Deformity Surgery
Led by Hospital for Special Surgery, New York · Updated on 2026-04-28
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the use of tranexamic acid (TXA) in adult patients undergoing spinal deformity surgery, a procedure known for significant blood loss that often requires blood transfusions and can lead to complications. This study aims to explore whether adding topical TXA to the standard intravenous TXA treatment can further reduce blood loss, drainage, transfusion needs, and hospital stay length. The trial is a prospective, randomized, quadruple-blinded, placebo-controlled study focusing on adult spinal deformity cases involving surgery of five or more levels with pelvic extension. Participants will receive intravenous TXA according to hospital protocol, starting with a loading dose followed by maintenance dosing during surgery. Additionally, one group will receive a topical TXA solution applied directly to the surgical site for five minutes after instrumentation, while the control group will receive a placebo solution in the same manner. Excess solution in both groups will be suctioned away without cell saver use. This approach mirrors successful practices in other types of orthopedic surgery but has not yet been studied in spinal deformity procedures. During the study, researchers will assess blood loss by measuring postoperative drainage over 48 hours and track perioperative blood transfusions, blood loss within 72 hours, adverse events up to 30 days after surgery, and hospital length of stay. Safety and efficacy will be closely monitored throughout the perioperative period. The total participation timeline includes surgery and follow-up assessments extending to 30 days postoperatively to capture relevant outcomes related to blood management and recovery.
CONDITIONS
Brief Title
Tranexamic Acid in Adult Spinal Deformity Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years
- Scheduled for posterior spinal fusion surgery involving 5 or more levels
- Surgery includes fusion to the pelvis
- Diagnosis of adult scoliosis or degenerative joint disease
You will not qualify if you...
- Use of anterior surgical approach
- History or presence of uncorrected dural tear
- Preoperative autologous blood donation
- Renal insufficiency (creatinine >1.5 or creatinine clearance <30ml/min)
- Hepatic insufficiency (AST, ALT elevated twice the upper normal limit)
- Seizure disorder or prior seizure
- Recent thromboembolic events (stroke, TIA, DVT, PE) within 1 year
- Hypercoagulability conditions
- Recent coronary artery disease events within 1 year
- Atrial fibrillation
- Use of anticoagulants that cannot be stopped at least 3 days before surgery
- Use of aspirin 325 mg that cannot be stopped 10 days before surgery
- Bleeding disorders or abnormal coagulation tests
- Preexisting anemia with hemoglobin less than 10 g/dL
- Color blindness or color vision disturbances
- Leukemia or active cancer
- Religious restrictions on blood transfusion
- Pregnancy or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Surgery day plus immediate perioperative period
Participants undergo spinal deformity surgery while receiving intravenous tranexamic acid. Additionally, they receive either topical tranexamic acid or a placebo applied during surgery to reduce blood loss.
1 surgical visit (in-person)
Duration - Up to 30 days postoperatively
Participants are monitored for perioperative blood loss, adverse events, blood transfusions, and recovery outcomes up to 30 days after surgery.
Follow-up visits as per hospital protocol within 30 days
Trial Site Locations
Total: 1 location
1
Hospital for Special Surgery
New York, New York, United States, 10021
Actively Recruiting
Research Team
J
Jordan A Gruskay, MD
E
Evangelia Zgonia, BA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here