Actively Recruiting

Phase 3
Age: 18Years - 80Years
All Genders
NCT03553186

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

450 weeks

Total Duration

On this page

AI-Summary

What this Trial 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. 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.

CONDITIONS

Official Title

Tranexamic Acid in Adult Spinal Deformity Surgery

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 80 years
  • Scheduled for posterior spinal fusion surgery involving 5 or more levels
  • Planned fusion extending to the pelvis
Not Eligible

You will not qualify if you...

  • Use of anterior surgical approach
  • History or presence of unrepaired dural tear
  • Preoperative autologous blood donation
  • Kidney dysfunction (creatinine >1.5 or creatinine clearance <30 ml/min)
  • Liver dysfunction (AST or ALT greater than twice the upper limit of normal)
  • Seizure disorder or prior seizures
  • Blood clots (stroke, TIA, deep vein thrombosis, pulmonary embolism) within 1 year
  • Known hypercoagulability conditions
  • Coronary artery disease within 1 year (stent, heart attack, positive stress test)
  • Atrial fibrillation
  • Use of anticoagulant medications that cannot be stopped before surgery
  • Bleeding disorders or abnormal coagulation blood tests
  • Anemia with hemoglobin less than 10 g/dL
  • Color blindness or color vision disturbance
  • Leukemia or active cancer
  • Religious restrictions against blood transfusion
  • Pregnancy or currently breastfeeding

AI-Screening

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Trial Site Locations

Total: 1 location

1

Hospital for Special Surgery

New York, New York, United States, 10021

Actively Recruiting

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Research Team

J

Jordan A Gruskay, MD

CONTACT

E

Evangelia Zgonia, BA

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Tranexamic Acid in Adult Spinal Deformity Surgery | DecenTrialz