Home › Surgical Blood Loss › NCT03553186

Tranexamic Acid in Adult Spinal Deformity Surgery

Topical Tranexamic Acid as a Adjunct to Intravenous Tranexamic Acid in Adult Spinal Deformity Surgery

Who can join

Ages 18 to 80 · All sexes

Inclusion Criteria:

* Age 18-80
* 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

About the study

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.

What is being tested

• Tranexamic Acid 100 MG/ML (drug)
• Placebo (drug)

Sponsor: Hospital for Special Surgery, New York · Participants: 100 · Started: Jul 11, 2018

Contact the study team

• Jordan A Gruskay, MD · Phone: 2034647759
• Evangelia Zgonia, BA · Phone: 2127742837

Official record on ClinicalTrials.gov — NCT03553186

Locations in the U.S.

Conditions

• Surgical Blood Loss

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.