RecruitingPhase 3NCT03553186

Tranexamic Acid in Adult Spinal Deformity Surgery

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


Sponsor

Hospital for Special Surgery, New York

Enrollment

100 participants

Start Date

Jul 11, 2018

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

Major spinal deformity surgery — such as correction of adult scoliosis involving five or more vertebrae — is associated with substantial blood loss, often requiring blood transfusions. This trial tests whether tranexamic acid, a drug that reduces bleeding by preventing blood clots from dissolving prematurely, can reduce blood loss and transfusion requirements in these large spinal operations. Reducing blood loss in spinal surgery has real benefits: fewer transfusions means lower infection risk, fewer transfusion reactions, shorter hospital stays, and potentially faster recovery. The study compares patients who receive tranexamic acid with those who receive standard care. You may be eligible if: - You are between 18 and 80 years old - You are scheduled for a long posterior spinal fusion of 5 or more levels for adult scoliosis or degenerative joint disease - Your fusion includes the pelvis You may NOT be eligible if: - You have kidney or liver insufficiency - You have a history of seizures - You have had a blood clot (stroke, TIA, DVT, or pulmonary embolism) within the past year - You have atrial fibrillation or coronary artery disease with a stent or heart attack within the past year - You have a bleeding disorder or are on anticoagulant medication that cannot be stopped before surgery - You are pregnant or breastfeeding - You have active cancer or leukemia Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGTranexamic 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.

DRUGPlacebo

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.


Locations(1)

Hospital for Special Surgery

New York, New York, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03553186


Related Trials