Bernabeu Wittel, MáximoAparicio, ReyesRomero, ManuelMurcia Zaragoza, JoséMonte Secades, RafaelRosso-Fernández, ClaraMontero Saez, AbelardoRuiz Cantero, AlbertoMelero Bascones, MaríaPAHFRAC-01 investigators2018-11-282018-11-282012-02-21https://hdl.handle.net/2445/126533Background: 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/Design: 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. Discussion: 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: NCT01154491.8 p.application/pdfengcc by (c) Bernabeu Wittel et al., 2012http://creativecommons.org/licenses/by/3.0/es/Articulació coxofemoralFracturesTransfusió de sangHip jointBlood transfusioninfo:eu-repo/semantics/article2018-07-24info:eu-repo/semantics/openAccess