Tranexamic Acid to Reduce Blood Loss in Spine Trauma Surgery
Status:
Recruiting
Trial end date:
2021-07-01
Target enrollment:
Participant gender:
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.