title: [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].
abstract: BACKGROUND
  There are no previous studies evaluating the effect of intravenous iron therapy on functional and cognitive status of patients with hip fracture (HF).
  
  
  METHODS
  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.
  
  
  RESULTS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: 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.
authors.forename: Rafael
authors.initials: R
authors.lastname: Bielza Galindo
authors.affiliation: Sección de Farmacología. Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, San Sebastián de los Reyes, España.
authors.forename: Jesús
authors.initials: J
authors.lastname: Llorente Gutiérrez
authors.affiliation: Servicio de Traumatología, Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, San Sebastián de los Reyes, España.
authors.forename: José Luis
authors.initials: JL
authors.lastname: Pérez González
authors.affiliation: Sección de Hematología, Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, San Sebastián de los Reyes, España.
authors.forename: Asunción
authors.initials: A
authors.lastname: Mora Casado
authors.affiliation: Servicio de Traumatología, Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, San Sebastián de los Reyes, España.
authors.forename: David
authors.initials: D
authors.lastname: Blanco Díaz
authors.affiliation: Servicio de Traumatología, Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, San Sebastián de los Reyes, España.
authors.forename: Javier
authors.initials: J
authors.lastname: Escalera Alonso
authors.affiliation: Área de Geriatría, Servicio de Medicina Interna y Geriatría, Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, San Sebastián de los Reyes, España.
authors.forename: Adoración
authors.initials: A
authors.lastname: Morales Fernández
authors.affiliation: Área de Geriatría, Servicio de Medicina Interna y Geriatría, Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, San Sebastián de los Reyes, España.
authors.forename: Cristina
authors.initials: C
authors.lastname: Molano Ortiz
authors.affiliation: Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, San Sebastián de los Reyes, España.
authors.forename: Beredys Esmirla
authors.initials: BE
authors.lastname: García López
authors.affiliation: Análisis Clínicos, Laboratorio de Urgencias, Hospital Infanta Sofía- BR Salud, San Sebastián de los Reyes, España.
authors.forename: Nazaret
authors.initials: N
authors.lastname: Del Amo Del Arco
authors.affiliation: Sección de Farmacología. Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, San Sebastián de los Reyes, España.
authors.forename: Juan Pablo
authors.initials: JP
authors.lastname: Barro Ordovas
authors.affiliation: Área de Geriatría, Servicio de Medicina Interna y Geriatría, Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, San Sebastián de los Reyes, España.
authors.forename: Estefanía
authors.initials: E
authors.lastname: Arias Muñana
authors.affiliation: Área de Geriatría, Servicio de Medicina Interna y Geriatría, Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, San Sebastián de los Reyes, España.
authors.forename: Marta
authors.initials: M
authors.lastname: Neira Álvarez
authors.affiliation: Escuela de Doctorado e Investigación, Universidad Europea de Madrid, España.
authors.forename: David
authors.initials: D
authors.lastname: Sanz Rosa
authors.affiliation: Área de Geriatría, Servicio de Medicina Interna y Geriatría, Hospital Universitario Infanta Sofía, Universidad Europea de Madrid, San Sebastián de los Reyes, España.
authors.forename: Jorge Fco
authors.initials: JF
authors.lastname: Gómez Cerezo
mesh_terms: D000368:Aged; D003693:Delirium / Q000453:epidemiology*; D004311:Double-Blind Method; D005260:Female; D000077605:Ferric Oxide, Saccharated / Q000008:administration & dosage*; D006397:Hematinics / Q000008:administration & dosage*; D006620:Hip Fractures / Q000601:surgery*; D006760:Hospitalization; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D011183:Postoperative Complications / Q000453:epidemiology*; D020127:Recovery of Function
chemical_list: D006397:Hematinics; D000077605:Ferric Oxide, Saccharated
keywords: Delirium; Ferroterapia intravenosa; Fractura de cadera; Functional recovery; Hip fracture; Intravenous iron therapy; Recuperación funcional