title: Ferric carboxymaltose with or without erythropoietin in anemic patients with hip fracture: a randomized clinical trial.
abstract: The increasing incidence of osteoporotic hip fracture (HF) has raised the requirements of red blood cell (RBC) transfusions, whereas this scarce resource may cause morbidity and mortality.
  
  
  
  This study was a multicenter, randomized, double-blind, clinical trial that aimed to assess efficacy of ferric carboxymaltose (FCM) with or without erythropoietin (EPO) in reducing RBC transfusion in the perioperative period of HF. Participants (patients > 65 years admitted with HF and hemoglobin [Hb] levels of 90-120 g/L) were randomly assigned to receive a preoperative single dose of 1 g of FCM (short intravenous [IV] infusion over 15 min), plus 40,000 IU of subcutaneous EPO (EPOFE arm); versus 1 g of IV FCM plus subcutaneous placebo (FE arm); and versus IV and subcutaneous placebo (placebo arm). Primary endpoint was the percentage of patients who received RBC transfusion, and secondary endpoints were the number of RBC transfusions per patient, survival, hemoglobinemia, and health-related quality of life (HRQoL; by means of Short Form 36 Version 2 questionnaire).
  
  
  
  A total of 306 patients (85% women, mean age 83 ± 6.5 years) were included. A total of 52, 51.5, and 54% of patients required RBC transfusion in the EPOFE, FE, and placebo arms, respectively, with no significant differences in the number of RBC transfusions per patient, survival, HRQoL, and adverse events among treatment groups. A significant increase in Hb levels was achieved at discharge (102 g/L vs. 97 g/L) and 60 days after discharge (125 g/L vs. 119 g/L) in the EPOFE arm with respect to placebo arm; in addition, a higher rate of patients recovered from anemia in the EPOFE arm with respect to the placebo arm (52% vs. 39%), 60 days after discharge.
  
  
  
  Preoperative treatment with FCM alone or in combination with EPO improved recovery from postoperative anemia, but did not reduce the needs of RBC transfusion in patients with HF.
authors.affiliation: Hospital Universitario Virgen del Rocío, Sevilla, Spain. wittel@cica.es.
authors.forename: Máximo
authors.initials: M
authors.lastname: Bernabeu-Wittel
authors.affiliation: Hospital Infanta Elena, Huelva, Spain.
authors.forename: Manuel
authors.initials: M
authors.lastname: Romero
authors.affiliation: Hospital Universitario Virgen del Rocío, Sevilla, Spain.
authors.forename: Manuel
authors.initials: M
authors.lastname: Ollero-Baturone
authors.affiliation: Hospital San Juan de Dios del Aljarafe, Sevilla, Spain.
authors.forename: Reyes
authors.initials: R
authors.lastname: Aparicio
authors.affiliation: Hospital de la Vega Baja, Alicante, Spain.
authors.forename: José
authors.initials: J
authors.lastname: Murcia-Zaragoza
authors.affiliation: Hospital Universitario Virgen del Rocío, Sevilla, Spain.
authors.forename: Manuel
authors.initials: M
authors.lastname: Rincón-Gómez
authors.affiliation: Hospital Lucus Augusti, Lugo, Spain.
authors.forename: Rafael
authors.initials: R
authors.lastname: Monte-Secades
authors.affiliation: Hospital General Universitario de Albacete, Albacete, Spain.
authors.forename: María
authors.initials: M
authors.lastname: Melero-Bascones
authors.affiliation: Hospital Universitario Virgen del Rocío, Sevilla, Spain.
authors.forename: Clara M
authors.initials: CM
authors.lastname: Rosso
authors.affiliation: Hospital de la Serranía, Málaga, Spain.
authors.forename: Alberto
authors.initials: A
authors.lastname: Ruiz-Cantero
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000188:drug therapy*; D004311:Double-Blind Method; D017707:Erythrocyte Transfusion; D004921:Erythropoietin / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage / Q000627:therapeutic use*; D006620:Hip Fractures / Q000188:drug therapy* / Q000628:therapy; D006801:Humans; D008297:Male; D008320:Maltose / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D011788:Quality of Life; D016896:Treatment Outcome
chemical_list: D005290:Ferric Compounds; D004921:Erythropoietin; C522335:ferric carboxymaltose; D008320:Maltose