A Phase IV Trial of a Hospital Policy of Tranexamic Acid Use to Reduce Transfusion in Major Non-cardiac Surgery (TRACTION): A Pragmatic Randomized Cluster Crossover Trial
A Phase IV trial of a hospital policy of Tranexamic acid to reduce transfusion in major non-cardiac surgery.
∙ Hospital sites will be included in the trial if anesthesia and hospital leadership agree to manage patients as per the policy being implemented and evaluated in the trial.
• Patients \>/= 18 years of age undergoing major non-cardiac surgery (a state of hyperfibrinolysis)
• Inpatient surgeries with an estimated \>/= 5% risk of RBC transfusion, including open surgeries or laparoscopic surgeries with an estimated duration of \>/= 3 hours
∙ Examples of eligible surgeries could include (but are not limited to):
⁃ General surgery (esophagectomy, gastrectomy, gastric repair, small bowel repair or resection, ostomy formation, colon/rectum repair or resection, colostomy, splenectomy, hepatectomy, pancreatectomy, resection of abdominal mass)
⁃ Orthopedics (hip fracture repair, pelvic fixation, femur repair / fixation, shoulder / humerus open reduction internal fixation, lower extremity amputation)
⁃ Spine (vertebrectomy, surgery involving \>/= 3 levels)
⁃ Otolaryngology (glossectomy, mandibulectomy, radical laryngectomy)
⁃ Thoracic (lung resection or decortication)
⁃ Vascular (arterial bypass / endarterectomy / aneurysmorrhaphy involving the aorta or proximal vessels off the aorta)
⁃ Gynecology (hysterectomy)
⁃ Urology (nephrectomy, cystectomy, prostatectomy, pelvic exenteration)
⁃ Plastic surgery (large neoplasm resections, burns or debridements)
‣ Surgeries anticipated to be associated with 5% or greater risk of RBC transfusion in hospital as per the surgical team.