Orthopedic Surgery Clinical Trial
Official title:
Impact of Tranexamic Acid on Red Blood Cell Transfusion in Spinal Surgery
Spinal surgery may be associated with substantial blood loss which often requires
erythrocyte transfusion. Transfusion of red blood cells (RBC) is not free of adverse events
and has been associated with increased risks of infection, and globally higher morbidity and
mortality.
Different techniques have been used to reduce perioperative blood losses and related
transfusions. Tranexamic acid has been used successfully in cardiac and hepatic surgery.
However, only a few studies have reported on the use of antifibrinolytic drugs in spinal
surgery.
This study was designed to assess the efficacy and safety of tranexamic acid in spinal
surgery for the reduction of RBC transfusion.
Hypothesis: the infusion of tranexamic acid during spinal surgery will reduce the risk of
receiving a RBC transfusion and, in those patients transfused, reduce the number of blood
products administered.
Administration of study drug
The administration of tranexamic acid/placebo will start following the induction of general
anesthesia. A bolus dose will be given intravenously over 30 minutes followed by a
continuous infusion administered up to 6 hours postoperatively.
Drugs used for anesthesia and postoperative analgesia will be left to the discretion of the
attending anesthesiologist. The administration of fluids (crystalloids, colloids and blood
products) will be recorded.
Transfusion: The transfusion trigger will be < 80 g/L during surgery if the situation is
stable. Transfusion may be initiated according to the attending anesthesiologist if the
situation is unstable. In the case of massive bleeding, transfusion will follow our standard
institutional protocol. The presence of microvascular bleeding at the surgical site will be
assessed by the surgeon. The Cellsaver will not be used.
The transfusion trigger during the postoperative period will be < 80 g/L. Blood losses and
the need for transfusion will be recorded from the moment of surgery up to 72 hours
postoperatively.
Laboratory testing
Before surgery: hemoglobin and coagulogram values will be recorded.
During surgery: the patient's coagulation status will be assessed using a thromboelastograph
(TEG). Thromboelastography is a simple coagulation test that enables evaluation of all
components of hemostasis. TEG testing will be performed at the induction of anesthesia and
every 2 hours throughout surgery. An additional blood sample for TEG analysis will be
collected at the end of surgery if the previous test was performed more than an hour before
the end of surgery.
After surgery: laboratory testing for hemoglobin, coagulogram, fibrinogen and d-dimer will
be performed in the recovery room. Hemoglobin will also be measured on postoperative days 1,
2 and 3. Blood samples to assess cardiac troponin levels will be collected on postoperative
days 1 and 2.
Ultrasound : Patients will have an ultrasound examination of the inferior limbs before
discharge from the hospital to detect deep vein thrombosis.
Follow-up The presence of adverse events during the course of the hospital stay will be
noted.
At 30 days, patients will be contacted by phone to detect any other adverse events.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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