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

评估对接受抗血小板治疗的股骨近端骨折患者缩短手术时间的策略(AFFEcT 研究):多中心随机对照临床试验的研究方案

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作者:Anaya Rafael, Rodriguez Mireia, Gil José María, Moral Victoria, Millan Angélica, Vilalta Noèlia, Claudia Erica, Antonijoan Rosa María, Reguant Francesca, Guilabert Patricia, Blanco Domingo, Mateo José, Merchán-Galvis Angela, Martinez-Zapata Maria Jose; AFFEcT study group

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 eitherThe 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

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