Impact of Tranexamic Acid on Red Blood Cell Transfusion in Spinal Surgery
Condition: Neurosurgery; Orthopedic Surgery; Red Blood Cell Transfusion
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Tranexamic Acid; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Bolus dose of 30 mg/kg of tranexamic acid followed by a continuous intravenous infusion of 16 mg/kg/h of tranexamic acid administered up to 6 hours after surgery.; Bolus dose of normal saline (NaCl 0.9%) of equivalent volume followed by a continuous intravenous infusion of NaCl 0.9% administered up to 6 hours after surgery.
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Red blood cell transfusion; Neurosurgery; Orthopedic surgery; Tranexamic acid; Surgical blood loss