title: Ferric carboxymaltose with or without erythropoietin for the prevention of red-cell transfusions in the perioperative period of osteoporotic hip fractures: a randomized contolled trial. The PAHFRAC-01 project.
abstract: BACKGROUND
  Around one third to one half of patients with hip fractures require red-cell pack transfusion. The increasing incidence of hip fracture has also raised the need for this scarce resource. Additionally, red-cell pack transfusions are not without complications which may involve excessive morbidity and mortality. This makes it necessary to develop blood-saving strategies. Our objective was to assess safety, efficacy, and cost-effictveness of combined treatment of i.v. ferric carboxymaltose and erythropoietin (EPOFE arm) versus i.v. ferric carboxymaltose (FE arm) versus a placebo (PLACEBO arm) in reducing the percentage of patients who receive blood transfusions, as well as mortality in the perioperative period of hip fracture intervention.
  
  
  METHODS
  Multicentric, phase III, randomized, controlled, double blinded, parallel groups clinical trial. Patients > 65 years admitted to hospital with a hip fracture will be eligible to participate. Patients will be treated with either a single dosage of i.v. ferric carboxymaltose of 1 g and subcutaneous erythropoietin (40.000 IU), or i.v. ferric carboxymaltose and subcutaneous placebo, or i.v. placebo and subcutaneous placebo. Follow-up will be performed until 60 days after discharge, assessing transfusion needs, morbidity, mortality, safety, costs, and health-related quality of life. Intention to treat, as well as per protocol, and incremental cost-effectiveness analysis will be performed. The number of recruited patients per arm is set at 102, a total of 306 patients.
  
  
  CONCLUSIONS
  We think that this trial will contribute to the knowledge about the safety and efficacy of ferric carboxymaltose with/without erythropoietin in preventing red-cell pack transfusions in patients with hip fracture. CLINICALTRIALS.GOV IDENTIFIER: NCT01154491.
authors.affiliation: Hospital Universitario Virgen del Rocío, Sevilla, Spain. wittel@cica.es
authors.forename: Máximo
authors.initials: M
authors.lastname: Bernabeu-Wittel
authors.forename: Reyes
authors.initials: R
authors.lastname: Aparicio
authors.forename: Manuel
authors.initials: M
authors.lastname: Romero
authors.forename: José
authors.initials: J
authors.lastname: Murcia-Zaragoza
authors.forename: Rafael
authors.initials: R
authors.lastname: Monte-Secades
authors.forename: Clara
authors.initials: C
authors.lastname: Rosso
authors.forename: Abelardo
authors.initials: A
authors.lastname: Montero
authors.forename: Alberto
authors.initials: A
authors.lastname: Ruiz-Cantero
authors.forename: María
authors.initials: M
authors.lastname: Melero-Bascones
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000740:Anemia / Q000188:drug therapy / Q000517:prevention & control / Q000628:therapy*; D003131:Combined Modality Therapy / Q000379:methods; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D017707:Erythrocyte Transfusion / Q000706:statistics & numerical data*; D004921:Erythropoietin / Q000627:therapeutic use*; D005260:Female; D005290:Ferric Compounds / Q000627:therapeutic use*; D006620:Hip Fractures / Q000150:complications* / Q000401:mortality / Q000601:surgery; D006801:Humans; D008297:Male; D008320:Maltose / Q000031:analogs & derivatives* / Q000627:therapeutic use; D058866:Osteoporotic Fractures / Q000150:complications* / Q000401:mortality / Q000601:surgery; D019106:Postoperative Hemorrhage / Q000150:complications / Q000401:mortality / Q000517:prevention & control; D012107:Research Design; D016896:Treatment Outcome
chemical_list: D005290:Ferric Compounds; D004921:Erythropoietin; C522335:ferric carboxymaltose; D008320:Maltose