Recruiting
Phase 2
Phase 3

Tranexamic Acid

Sponsor:

Columbia University

Code:

NCT02314988

Conditions

Spinal Injuries

Spinal Deformity

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Tranexamic Acid

Placebo

Study Details

Brief summary:

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

Spinal Injuries

Spinal Deformity

Study ID

NCT02314988

Start date

Jun 15, 2020

Status verified date

May, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

252 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Intervention

Subjects will receive tranexamic acid on the surgical wound.

placebo comparator: Placebo control

Subjects will receive placebo (saline solution) on the surgical wound.

Interventions

Tranexamic Acid

3.0 grams of tranexamic acid will be poured in the surgical field and left in contact for five minutes. Subsequently, excess study solution will be suctioned away without touching the surrounding tissue surfaces and then the would closed without irrigation or manipulation.

TXA solution will be prepared using a dose of 3 grams of tranexamic acid combined with 70 mL of sterile normal saline, for a total volume of 100 mL.

Placebo

Placebo will be poured in the surgical field and left in contact for five minutes. Subsequently, excess solution will be suctioned away without touching the surrounding tissue surfaces and then the would closed without irrigation or manipulation.

The placebo solution will be 100 mL of sterile normal saline.

Primary outcome measure

  • Maximal drop in systemic hemoglobin concentration during the postoperative period [ Time Frame: Patients will be followed through postoperative day 4 ]

Central Contacts and Locations

Central contacts

Locations

University of California San Francisco Medical Center

Recruiting

San Francisco, California, United States, 94149

Principal Investigator:

Shane Burch, MD

Norton Leatherman Spine Center

Recruiting

Louisville, Kentucky, United States, 40202

Principal Investigator:

Charles H. Crawford, MD

NYP/The Allen Hospital - CUIMC

Recruiting

New York, New York, United States, 10032

Contacts

Ronald A. Lehman, MD

rl2781@cumc.columbia.edu

Principal Investigator:

Ronald A. Lehman, MD

Duke University Medical Center

Recruiting

Durham, North Carolina, United States, 27710

Principal Investigator:

Christopher Shaffrey, MD

More Information

Sponsor

Columbia University

Last update posted

May 6, 2026

Last verified

May, 2026

Keywords

  • Tranexamic acid
  • Antifibrinolytic
  • Perioperative blood loss
  • Postoperative drain output
  • Allogenic transfusion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Columbia University on 2026-05-06.