Grant: Catalyst Grant: SPOR Innovative Clinical Trials (iCT)

Bleeding and the need for red blood cell transfusion is common in major surgical procedures. Transfusion associated with major surgery accounts for 50% of all transfused blood. Transfusion is expensive and blood is a scare resource. In preparation for large randomized control trial evaluating an expensive drug to reduce the need for transfusion in major non-cardiac surgery, we will conduct a pilot randomized control trial of tranexamic acid. Tranexamic acid is a drug that prevents clots from dissolving. It s used routinely in cardiac surgery and some orthopaedic procedures, but it's effectiveness and safety in most other surgical procedures has not been evaluated. In our proposed trial we will conduct a pilot innovative randomized controlled trial (called a registry-based randomized trial) to evaluate the feasibility of a large registry-based randomized controlled trial. 300 patients will be enrolled in the trial. Patients will receive 1 gram of tranexamic acid intravenously (in their veins) at the start of the procedure followed by an infusion of the drug. The primary aim of the trial is to evaluate our ability to recruit enough patients per month to demonstrate the feasibility of a larger trial designed to answer the question "is tranexamic acid safe and effective to reduce transfusion in patients undergoing high-risk non-cardiac surgery. Secondary outcomes of our pilot feasibility trial are 1) Electronic identification of eligible patients; 2) Data completeness; 3) Data confirmation; validation of VTE diagnostic testing; and 4) Protocol compliance. The pilot trial will ensure the methods of electronic data linkage and capture are reliable and representative, and will demonstrate the feasibility of a large (n =5800 patients) pragmatic, registry-based, randomized controlled trial (RCT).