RecruitingPhase 2Phase 3NCT02314988

Tranexamic Acid to Reduce Blood Loss in Spine Surgery

Topical Application of Tranexamic Acid (CYKLOKAPRON®) to Reduce Blood Loss During Spine Surgery

Sponsor

Columbia University

Enrollment

252 participants

Start Date

Jun 15, 2020

Study Type

INTERVENTIONAL

Conditions

Spinal Deformity Spinal Injuries

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether tranexamic acid — a drug that helps blood clot — can reduce blood loss during complex spine surgery involving the thoracic or lumbar spine. Excessive bleeding during these procedures can require blood transfusions, and researchers want to know if this drug offers a safer alternative. You may be eligible if... - You are between 18 and 80 years old - You have a thoracic or lumbar spine injury (with or without nerve damage) that requires surgical fixation - Surgery is planned within 21 days of injury - You are undergoing a long spinal fusion (more than 5 levels) You may NOT be eligible if... - You have severe wound or soft tissue damage around the surgical site - You have an ongoing serious infection or sepsis - You have a known allergy to tranexamic acid - You have a history of seizures - You are pregnant or breastfeeding - You have significant kidney or liver problems - You have a history of blood clots (stroke, DVT, pulmonary embolism) - You have severe heart, lung, or bleeding disorders - You have color vision problems - You are already on anticoagulant or anti-inflammatory medications 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.

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Interventions

DRUGTranexamic 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.

DRUGPlacebo

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.