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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 |
Author: | Bernabeu Wittel, Máximo Aparicio, Reyes Romero, Manuel Murcia Zaragoza, José Monte Secades, Rafael Rosso-Fernández, Clara Montero Saez, Abelardo Ruiz Cantero, Alberto Melero Bascones, María PAHFRAC-01 investigators |
Keywords: | Articulació coxofemoral Fractures Transfusió de sang Hip joint Blood transfusion |
Issue Date: | 21-Feb-2012 |
Publisher: | BioMed Central |
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/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. |
Note: | Reproducció del document publicat a: https://doi.org/10.1186/1471-2474-13-27 |
It is part of: | BMC Musculoskeletal Disorders, 2012, vol. 13, num. 27 |
URI: | http://hdl.handle.net/2445/126533 |
Related resource: | https://doi.org/10.1186/1471-2474-13-27 |
Appears in Collections: | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
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