Safety of Tranexamic Acid in Reducing Bleeding in Adults Undergoing Spinal Surgery
Condition: Spine Surgery
Study type: Interventional
Phase: Phase 3

Summary: 
      Spinal fusion surgery can be associated with significant blood loss requiring allogeneic
      blood transfusion. Tranexamic acid is a synthetic amino acid with antifibrinolytic action
      that has been shown to reduce perioperative blood loss in patients undergoing cardiopulmonary
      bypass for cardiac bypass surgery, knee replacement and liver transplantation surgeries. The
      efficacy of antifibrinolytics for reduction of blood loss in major spine surgery has not been
      well studied in adult patients. The objective of this study is to determine the efficacy of
      tranexamic acid in reducing perioperative blood loss and blood transfusion in adults
      undergoing elective spinal fusion in a larger, multi-centered, randomized, double-blinded,
      placebo controlled trial.
    

Detailed description: 
      Spinal fusion can be associated with significant blood loss requiring allogeneic blood
      transfusion (ABT). Ongoing concerns about the costs, risks, and availability of allogeneic
      blood have prompted the implementation of multiple techniques (preoperative erythropoetin,
      autologous pre-donation, intra-operative blood salvage, and induced hypotension) to reduce
      the necessity of ABT. However, 28% of patients undergoing spinal fusion at the Toronto
      Western Hospital still receive ABT. Also, none of these modalities (with the exception of
      induced hypotension) actually reduce the amount of blood shed from the surgical wound; thus
      the severity of anemia is largely unaffected. Consequently, many of these patients can suffer
      from adverse effects of anemia postoperatively as well as potential complications from blood
      transfusions.

      The underlying assumption of the proposed study is that excessive fibrinolysis occurs during
      spinal fusion surgery. This can result in increased and recurrent blood loss, which can
      exacerbate the significant amount of bleeding already associated with major spine surgery.

      Tranexamic acid - an antifibrinolytic drug blocks the dissolution of hemostatic fibrin, which
      stabilizes fibrin structures, and thus may decrease blood loss secondary to increased
      fibrinolysis.

      This research proposal will test the following hypotheses:

        1. Tranexamic acid reduces the estimated perioperative blood loss in adult patients
           undergoing elective spinal fusion.

        2. Tranexamic acid reduces the need for blood transfusion in adult patients undergoing
           elective spinal fusion.

      This multi-centered trial will be valuable for establishing the efficacy and safety of
      tranexamic acid for reducing blood loss and allogeneic blood transfusion in adults having
      elective spinal fusion. Tranexamic acid is easy to administer, is relatively inexpensive, and
      has not been associated with significant adverse effects. If it is shown to be efficacious,
      it can be incorporated into routine clinical practice as part of the multi-modal
      perioperative blood conservation techniques currently used to reduce perioperative blood
      loss, transfusion and the risk of allogeneic blood transfusion.
    

Intervention name(s): Tranexamic acid; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Eligible patients who have consented to be in the study and have been randomised to be in Arm "A" will receive 10 mg/kg of tranexamic acid, and then a continuous infusion of 1 mg/kg/hr of tranexamic acid.; Eligible patients who have consented to be in the study and have been randomised to be in Arm "B" will receive 10 mg/kg of placebo followed by a continuous infusion of 1 mg/kg/hr of placebo.
Other intervention name(s): Tranexamic acid is known by the brand name Cyclokapron; Normal Saline is used as placebo
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: tranexamic acid; safety; efficacy; spine surgery; spinal fusion and decompression; adult; perioperative; blood loss; bleeding; blood transfusion