The purpose of this study is to evaluate two dosing protocols for tranexamic acid (TXA), an anti-fibrinolytic used to decrease blood loss in adult patients undergoing complex, reconstructive spinal fusion surgeries.
After consent is obtained and the patient is enrolled in the trial, patients will be assigned de-identified, unique identification (ID) numbers. Randomization of these IDs to either low or high dose TXA will occur via a computer generated random assignment. Given the variations that may exist in surgical technique (e.g. performance of osteotomies), stratified randomization will be performed by attending surgeon. Based upon the randomization, the pharmacy will prepare TXA for one of two intravenous dosing protocols: 1. Low Dose (Standard of Care/Control): Loading Dose 10mg/kg given over 15 minutes, followed by 1mg/kg/hr via continuous infusion 2. High Dose (Study Group): Loading Dose 50mg/kg given over 15 minutes, followed by 5mg/kg/hr via continuous infusion. The surgeon, anesthesia team, and operating room staff will be blind to the concentration of TXA in the medications received. Treatments may be "unblinded" at the discretion of the surgeon and anesthesiologist, in cases of extreme blood loss. If additional anti-fibrinolytics are given, the change in dose will be recorded. Post-operative care will be the same as any other patient and data collection will be information contained in the patient's medical record that is part of routine, standard of care.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
64
Washington University School of Medicine
St Louis, Missouri, United States
Blood Loss
To compare the estimated blood loss in patients undergoing complex, reconstructive, spinal fusion surgeries receiving one of two dosing protocols for the anti-fibrinolytic, TXA. Estimated blood loss was calculated by suction canister volume minus intraoperative irrigation fluid plus blood content in sponges as estimated by weight for all cases.
Time frame: This outcome is measured during surgery, from exposure to wound closure, approximately 8 hours.
Red Blood Cell Transfusions
To compare the mean volume (mL) of packed red blood cell (PRBC) transfusions given to the two groups. Volumes of RBC vary from bag to bag and real volumes will be recorded as provided by the blood bank.
Time frame: Participants will be followed for the duration of their hospital stay measured from day of surgery to day of discharge from the hospital, approximately 7 days.
Number of Patients Sustaining Intraoperative or 90 Day Complications
To compare the rates of intraoperative complications and 90 day complications observed in the two groups.
Time frame: Perioperative complications were defined as complications occurring within 90 days of surgery.
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