Evaluation of a strategy to shorten the time to surgery in patients on antiplatelet therapy with a proximal femur fracture (AFFEcT Study): Study protocol for a multicenter randomized controlled clinical trial

INTRODUCTION: Patients with femur fracture benefit from early surgery. Recent reports suggest that regional anesthesia may be superior to general anesthesia in these patients. Early surgery under spinal anesthesia could be performed safely by determining platelet function in patients receiving antiplatelet agents. METHODS: Multicenter, randomized, open-label, parallel clinical trial expected to include 156 patients ≥ 18 years of age under chronic treatment with antiplatelet agents who develop a proximal femur fracture. Exclusion criteria: presence of multiple or pathological fractures, current treatment with vitamin K antagonists or new oral anticoagulants, and congenital or acquired coagulopathy. Patients will be randomized to either: 1. a guided early surgery strategy in which preoperative platelet function will be assessed at emergency department admission or 2. a conventional strategy in which surgery under neuraxial anesthesia will be scheduled according to the margin of safety time established for the specific antiplatelet agent. The primary endpoint is time (hours) from admission to surgery. Secondary endpoints include: platelet function; postoperative bleeding; medical-surgical complications; perioperative and 1-year mortality; quality of life; length of hospital stay; cost-effectiveness; and cost-utility. Follow-up assessments will be performed during hospital admission and at 1, 6, and 12 months after surgery. POTENTIAL IMPACT OF THE STUDY: The determination of platelet function at admission to the emergency department in patients with femoral fracture receiving antiplatelet therapy may permit earlier surgery under spinal anesthesia, thus shortening the hospital stay and reducing the risk of complications. These advantages associated with early surgery could positively impact patient well-being and also reduce treatment-related healthcare costs. ETHICS AND DISSEMINATION: The study has been approved by the ethics committees at all participating centers. Their results will be disseminated in congresses and published in peer reviewed journals.