Actively Recruiting
Tranexamic Acid to Reduce Blood Loss in Spine Surgery
Led by Columbia University · Updated on 2026-05-06
252
Participants Needed
4
Research Sites
367 weeks
Total Duration
On this page
Sponsors
C
Columbia University
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is designed to evaluate the efficacy of topical tranexamic acid to reduce perioperative blood loss, reduction in postoperative drain output and allogenic transfusion requirements. The proposed study will be a prospective, randomized, double-blind (subject, surgeons, investigators, research coordinators) placebo-controlled study. Patients requiring posterior spinal fusion will be enrolled for this study. Furthermore, patients undergoing elective complex deformity surgery will also be enrolled. Both populations of patients will be randomized into two groups. Group I will receive standard of care operative fixation with topical tranexamic acid intervention (test); Group II will receive standard of care operative fixation with normal saline (placebo) intervention. This study will have a 2-year follow-up and will consist of three periods: screening/enrollment phase up to 21 days from the day of injury to the day of randomization and operative intervention, an inpatient data collection period for 4 days postoperative, and then a follow-up period for 2-years postoperative (visits occurring at 16 weeks, 1 year, and 2 year) time points.
CONDITIONS
Official Title
Tranexamic Acid to Reduce Blood Loss in Spine Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Thoracic or lumbar spinal column injury requiring surgical fixation
- Surgical fixation planned within 21 days of injury
- Adult patients undergoing long segment (>5 fusion levels) posterior spinal fusions
You will not qualify if you...
- Age under 18 or over 80 years
- Severe soft tissue damage around the surgical site preventing proper wound closure
- Physiologic instability or ongoing infection/sepsis
- Use of intravenous tranexamic acid before the study
- Ballistic spinal column injury
- Allergy to tranexamic acid
- Color vision disturbances or color blindness
- Preoperative hemoglobin less than 7 g/dL, or less than 10 g/dL with symptoms or comorbidities requiring blood transfusion
- Refusal of consent for blood products
- Participation in another clinical trial
- Moderate or severe traumatic brain injury preventing participation in outcome surveys
- Subarachnoid hemorrhage
- Use of Factor IX Complex or Anti-inhibitor Coagulant concentrates
- Use of anticoagulants or non-steroid anti-inflammatory drugs shortly before surgery
- Fibrinolytic disorders needing antifibrinolytic treatment during surgery
- Disseminated intravascular coagulation (DIC)
- Coagulopathy as defined by specific blood test abnormalities
- History of thromboembolic disease such as stroke, deep vein thrombosis, or pulmonary embolism
- Injury to upper urinary tract or ureters
- Pregnancy or breastfeeding
- Significant kidney or liver dysfunction
- Major comorbidities including alcohol or drug abuse, bone metabolism disorders, connective tissue disorders, heart disease, severe lung disease, diabetes, immunosuppression, vascular disease, severe brain injury, skeletal malignancies, or prior radiation therapy to the skeleton
- History of seizures or use of medications lowering seizure threshold
- History of dural tear or open subdural space
AI-Screening
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Trial Site Locations
Total: 4 locations
1
University of California San Francisco Medical Center
San Francisco, California, United States, 94149
Actively Recruiting
2
Norton Leatherman Spine Center
Louisville, Kentucky, United States, 40202
Actively Recruiting
3
NYP/The Allen Hospital - CUIMC
New York, New York, United States, 10032
Actively Recruiting
4
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
R
Ronald A Lehman, MD
CONTACT
M
Matthew J. Cooney
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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