Study of Drugs for Use in Posterior Spinal Fusion for Spinal Deformity

Full Title of Study

Prospective, Randomized Study of Tranexamic acid, Aminocaproic acid, or Controls in Posterior Spinal Fusion for Spinal Deformity (R# 08-779)

Purpose of Study

Multilevel spinal fusion surgery has typically been associated with significant blood loss and transfusion requirements. The purpose of this study is to compare the relative efficacy of tranexamic acid (TXA) and epsilon aminocaproic acid (EACA), two drugs used to reduce blood loss, in adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis (NMS), or adult deformity (AD) patients.

Basic Inclusion Criteria (requirements for being included in study)

  • Age 10 to 85 years
  • Undergoing posterior thoracic and/or lumbar spinal surgery 6 levels or more for correction of AIS, NMS or AD
  • Body mass index (BMI) within the range 15-35

Basic Exclusion Criteria (reasons for being excluded from study)

  • Prior spinal surgery at the same vertebral levels
  • Religious or other beliefs limiting blood transfusion
  • Significant cardiac, pulmonary, hepatic, hematologic, or renal disease that may affect blood pressure, anesthesia intraoperatively, or coagulation
  • Current use of anticoagulant medication or abnormal coagulation profile preoperatively

Study Visit Requirements

Follow-up visits occur during patient's regularly scheduled office visits.

Principal Investigator

Thomas Errico, MD

Answers to frequently asked questions (FAQs) about clinical trials

For more information about enrolling in this study, please contact Alexandra Lee, or 212-598-6114