• Rev Esp Geriatr Gerontol · Jan 2018

    Randomized Controlled Trial Comparative Study

    [Intravenous iron, functional recovery and delirium in patients with hip fracture. FEDEREF study. Single-centre randomised, placebo-controlled, and double-blind clinical trial. 2014-001923-53: EudraCT number].

    • Rafael Bielza Galindo, Jesús Llorente Gutiérrez, José Luis Pérez González, Asunción Mora Casado, David Blanco Díaz, Javier Escalera Alonso, Adoración Morales Fernández, Cristina Molano Ortiz, Beredys Esmirla García López, Nazaret Del Amo Del Arco, Juan Pablo Barro Ordovas, Estefanía Arias Muñana, Neira ÁlvarezMartaMÁrea de Geriatría, Servicio de Medicina Interna y Geriatría, Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, San Sebastián de los Reyes, España., David Sanz Rosa, and Jorge Fco Gómez Cerezo.
    • Área de Geriatría, Servicio de Medicina Interna y Geriatría, Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, San Sebastián de los Reyes, España. Electronic address: rafabielza@hotmail.com.
    • Rev Esp Geriatr Gerontol. 2018 Jan 1; 53 (1): 38-44.

    IntroductionThere are no previous studies evaluating the effect of intravenous iron therapy on functional and cognitive status of patients with hip fracture (HF).Material And MethodsA 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.ResultsThe 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.ConclusionsThe 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.Copyright © 2017 SEGG. Publicado por Elsevier España, S.L.U. All rights reserved.

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