The purpose of this study is to see if Tranexamic Acid can safely reduce bleeding in people undergoing spinal fusion surgery.
This will be a multicenter, randomized, double-blind, parallel group study comparing tranexamic acid (test) to placebo (control) for reduction of perioperative blood loss after complex spinal fusion surgery (defined as T2 to Pelvis/Sacrum and greater than 4 Functional Spinal Units (4 discs/motion segments=5 Vertebral segments)). In addition to test and control treatments, all patients undergoing spinal fusion surgery will receive anesthesia and standard of care for blood loss including colloid/crystalloid fluid replacement and packed red cells, if necessary, according to a common multi-institutional protocol. Anesthesia will keep the mean arterial pressure as low as safe for the patient during exposure of surgery (estimated at 60-80 MAP). Patients will be randomized to receive either 30 mg/kg tranexamic acid as a one hour infusion (3 mL/kg) loading dose prior to start of procedure and as an infusion at 3 mg/kg/h (0.3 mL/kg/h) of tranexamic acid throughout the surgery in the test group; or, a one hour infusion at 3 mL/kg of 0.9% saline prior to start of the procedure and an infusion of 0.9% saline at 0.3 mL/kg/h in the control group. The maximum total dose will be 50 mg/kg. The active phase of the study will be until discharge postoperatively for efficacy measurements and at 6 weeks for safety follow-up. The randomization will be open only to the statistician generating the randomization sequence. All PI(s), study conduct and monitoring staff, as well as the subjects will be completely blinded to the treatments except in the case of emergency. The study will be terminated if ≥5/12 or 10/36 patients enrolled in the study are diagnosed with treatment related serious adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
5
Inactive ingredient mixture for injection without drug, intravenous infusion bags containing normal saline, manufactured and provided by Exela Pharma Sciences, LLC from a single batch / lot.
Tranexamic Acid Intravenous Infusion Bags (10 mg/mL), manufactured and provided by Exela Pharma Sciences, LLC from a single batch / lot.
Memorial Orthopaedic Surgery Group
Long Beach, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Rush University Medical Center - Division of Spine Surgery
Chicago, Illinois, United States
Spine Care Orthopedics - NYU Lagone Medical Center
New York, New York, United States
Total Blood Loss
The Total Blood Loss will be estimated based on the hemoglobin content of the blood prior to surgery (mg/dL) and at each of the desired post-surgery time-points (mg/dL). Blood samples for hemoglobin measurement will be collected prior to start of procedure, at the end of the procedure, at 24 h, and every 24 h thereafter until discharge and removal two subfascial drains.
Time frame: From time of surgery until discharge
Incidence of Autologous or Allogenic Blood Transfusion
Number of Units of autologous transfusion and allogenic transfusion
Time frame: From time of surgery until discharge
Total Measured Blood Loss
Estimated as 3x cell saver
Time frame: From time of surgery up to 24 hours after surgery
Number of Patients With Symptomatic Anemia Precipitated Transfusion
Number of patients with symptomatic anemia precipitated transfusion in each group
Time frame: Until discharge
Number of Patients With Adverse Events Related to Tranexamic Acid
Number of patients with adverse events related to tranexamic acid in each group
Time frame: up to 6 weeks
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