Tranexamic Acid to Reduce Blood Loss in Spine Trauma Surgery

Spinal Deformity Clinical Trial

Official title: Topical Application of Tranexamic Acid to Reduce Blood Loss During Complex Combat-related Spine Trauma Surgery

Status Recruiting

Clinical Trial 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 following high energy trauma who have sustained thoracic or lumbar spine fractures, dislocations or ligamentous injury with resultant instability 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 2 week, 16 week, 1 year, and 2 year) time points.

Clinical Trial Description

Reducing perioperative blood loss is critically important in the treatment of multiply injured combat casualties, and major blood loss during complex spine trauma surgery is a significant concern. Similar to previous studies in dental, cardiac, and total knee arthroplasty procedures, the use of topical tranexamic acid during complex combat related spine trauma surgery can be a cost-effective and simple route of administration to reduce blood loss, with no significant systemic effects. Patients would be expected to benefit immediately by decreasing blood loss and the need for blood transfusion postoperatively, thereby exposing them to less risk of transfusion reactions or disease transmission. This may also potentially decrease the rate of surgical site infection because patients have been found to have a significantly increased risk for surgical site infection after blood transfusion due to changes in the immune system, and by also decreasing the amount of blood that collects under the surgical wound, which serves as excellent medium for bacterial growth. The goal of the investigators study is to determine if the use of topical tranexamic acid (TXA) in the setting of complex spine trauma surgery reduces blood loss, and subsequently reduces the rate of allogenic blood transfusion and surgical site infection. ;

Related Conditions & MeSH terms

• Hemorrhage
• Spinal Deformity
• Spinal Injuries

• NCT number: NCT02314988
• Study type: Interventional
• Source: Columbia University
• Contact: Ronald A Lehman, MD
• Phone: 2129325067
• Email: rl2781@cumc.columbia.edu
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: June 15, 2020
• Completion date: July 2025