Recruiting
Phase 3

Tranexamic Acid

Sponsor:

Hospital for Special Surgery, New York

Code:

NCT03553186

Conditions

Spinal Deformity

Degenerative Lumbar Spinal Stenosis

Blood Loss, Surgical

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Tranexamic Acid 100 MG/ML

Placebo

Study Details

Brief summary:

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

Spinal Deformity

Degenerative Lumbar Spinal Stenosis

Blood Loss, Surgical

Study ID

NCT03553186

Start date

Jul 11, 2018

Status verified date

Mar, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: ivTXA + topical TXA

TXA lavage solution (200 cc sterile normal saline + 5 g tranexamic acid 100mg/ml (50cc)) will be poured into the surgical field and left in contact for five minutes. This will occur after instrumentation. Excess solution will be suctioned away using a non-cell saver suction.

IV txa will be given as (5mg/ml) loading dose (20mg/kg) over 15 minutes followed by 2 mg/kg/hr maintenance dosing as per hospital protocol

placebo comparator: IV TXA + topical placebo

Placebo solution (200 cc sterile normal saline + placebo TXA ampule (normal saline) (50cc)) will be poured into the surgical field and left in contact for five minutes. This will occur after pedicle screw instrumentation. Excess solution will be suctioned away using a non-cell saver suction.

IV txa will be given as (5mg/ml) loading dose (20mg/kg) over 15 minutes followed by 2mg/kg/hr maintenance dosing as per hospital protocol

Interventions

Tranexamic Acid 100 MG/ML

TXA lavage solution (200 cc sterile normal saline + 5 g tranexamic acid 100mg/ml (50cc)) will be poured into the surgical field and left in contact for five minutes. This will occur after instrumentation. Excess solution will be suctioned away using a non-cell saver suction.

Placebo

Placebo solution (200 cc sterile normal saline + placebo TXA ampule (50cc)) will be poured into the surgical field and left in contact for five minutes. This will occur after pedicle screw instrumentation. Excess solution will be suctioned away using a non-cell saver suction.

Primary outcome measure

  • Postoperative Drain output [ Time Frame: 48 hours ]

Central Contacts and Locations

Central contacts

Jordan A Gruskay, MD

2034647759gruskayj@hss.edu

Evangelia Zgonia, BA

2127742837zgonise@hss.edu

Locations

Hospital for Special Surgery

Recruiting

New York, New York, United States, 10021

Principal Investigator:

Han Jo Kim, MD

More Information

Sponsor

Hospital for Special Surgery, New York

Last update posted

Apr 28, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hospital for Special Surgery, New York on 2026-04-28.