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
1 Hospital Universitario Virgen del Rocío, Sevilla, Spain
2 Hospital San Juan de Dios del Aljarafe, Sevilla, Spain
3 Hospital Infanta Elena, Huelva, Spain
4 Hospital de la Vega Baja, Orihuela, Alicante, Spain
5 Complexo Hospitalario Xeral-Calde, Lugo, Spain
6 Hospital Universitario de Bellvitge, Barcelona, Spain
7 Hospital de la Serranía, Ronda, Málaga, Spain
8 Hospital General Universitario de Albacete, Albacete, Spain
9 Department of Internal Medicine, Hospitales Universitarios Virgen del Rocío, Avenida Manuel Siurot s/n., 41013 Sevilla, Spain
BMC Musculoskeletal Disorders 2012, 13:27 doi:10.1186/1471-2474-13-27Published: 21 February 2012
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.
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.
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.