Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
study ends around
Principal Investigator
by Shane Burch, MD

Description

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.

Official Title

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

Details

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 surgery reduces blood loss, and subsequently reduces the rate of allogenic blood transfusion and surgical site infection.

Keywords

Spinal Injuries, Spinal Deformity, Tranexamic acid, Antifibrinolytic, Perioperative blood loss, Postoperative drain output, Allogenic transfusion, Hemorrhage

Eligibility

Locations

  • UCSF Medical Center accepting new patients
    San Francisco California 94149 United States
  • Norton Leatherman Spine Center accepting new patients
    Louisville Kentucky 40202 United States
  • Duke University Medical Center accepting new patients
    Durham North Carolina 27710 United States
  • NYP/The Allen Hospital - CUIMC accepting new patients
    New York New York 10032 United States

Lead Scientist at UCSF

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Columbia University
ID
NCT02314988
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
Expecting 252 study participants
Last Updated