TY - JOUR 
A1 - Bielza Galindo, Rafael
AU - Llorente Gutiérrez, Jesús
AU - Pérez González, José Luis
AU - Mora Casado, Asunción
AU - Blanco Díaz, David
AU - Escalera Alonso, Javier
AU - Morales Fernández, Adoración
AU - Molano Ortiz, Cristina
AU - García López, Beredys Esmirla
AU - Amo del Arco, Nazaret del
AU - Barro Ordovas, Juan Pablo
AU - Arias Muñana, Estefanía
AU - Neira Álvarez, Marta
AU - Sanz Rosa, David
AU - Gómez Cerezo, Jorge Francisco
T1 - Hierro intravenoso, recuperación funcional y delirium en pacientes con fractura de cadera. Estudio FEDEREF. Ensayo clínico unicéntrico aleatorizado, controlado con placebo, doble ciego. Número EudraCT: 2014-001923-53

Y1 - 2018
SN - 15782747

UR - http://hdl.handle.net/11268/6327
AB - There are no previous studies evaluating the effect of intravenous iron therapy on functional and cognitive status of patients with hip fracture (HF). A single-centre randomised, placebo-controlled, double-blind and parallel treatment, clinical trial has been designed to assess the efficacy of intravenous iron therapy during the peri-operative period in elderly patients suffering from a HF. Blinding will be ensured by the packaging of the drug infusion system. On days 1, 3, and 5 from admission, the intervention group will receive 200mg Venofer® (iron sucrose) diluted in 100ml saline, and the control group 100ml saline, also on days 1, 3 and 5. Patients will received conventional treatment in ortho-geriatric unit of the Hospital Infanta Sofia. Functional variables (activities of daily living and walking), cognitive (cognitive status and delirium), surgical, demographic and clinical characteristics will be collected during admission in order to assess the impact of treatment. A safety analysis of the treatment will also performed. Patients will be followed-up at 3, 6, and 12 months. The study will attempt to provide evidence on the impact of the intravenous iron administration on functional recovery. It will be determined whether iron therapy negatively affects the incidence of post-operative delirium. Finally, report will be presented on the safety data of intravenous iron in elderly HF patients, as well as the impact on allogenic blood transfusion savings. The inclusion of elderly HF patients admitted to an ortho-geriatric unit, in a clinical trial, will help to improve the knowledge of the treatment impact on a usual scenario, and provide useful data for use in other units.
KW - Fracturas óseas en ancianos
KW - Delirio en ancianos
KW - Gerontología
LA - spa
ER -