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DC Field | Value | Language |
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dc.contributor.author | Bernabeu Wittel, Máximo | - |
dc.contributor.author | Aparicio, Reyes | - |
dc.contributor.author | Romero, Manuel | - |
dc.contributor.author | Murcia Zaragoza, José | - |
dc.contributor.author | Monte Secades, Rafael | - |
dc.contributor.author | Rosso-Fernández, Clara | - |
dc.contributor.author | Montero Saez, Abelardo | - |
dc.contributor.author | Ruiz Cantero, Alberto | - |
dc.contributor.author | Melero Bascones, María | - |
dc.contributor.author | PAHFRAC-01 investigators | - |
dc.date.accessioned | 2018-11-28T10:25:45Z | - |
dc.date.available | 2018-11-28T10:25:45Z | - |
dc.date.issued | 2012-02-21 | - |
dc.identifier.uri | http://hdl.handle.net/2445/126533 | - |
dc.description.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. | - |
dc.format.extent | 8 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | BioMed Central | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.1186/1471-2474-13-27 | - |
dc.relation.ispartof | BMC Musculoskeletal Disorders, 2012, vol. 13, num. 27 | - |
dc.relation.uri | https://doi.org/10.1186/1471-2474-13-27 | - |
dc.rights | cc by (c) Bernabeu Wittel et al., 2012 | - |
dc.rights.uri | http://creativecommons.org/licenses/by/3.0/es/ | * |
dc.source | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) | - |
dc.subject.classification | Articulació coxofemoral | - |
dc.subject.classification | Fractures | - |
dc.subject.classification | Transfusió de sang | - |
dc.subject.other | Hip joint | - |
dc.subject.other | Blood transfusion | - |
dc.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 | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.date.updated | 2018-07-24T12:56:26Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
Appears in Collections: | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
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Bernabeu-WittelM.pdf | 620.93 kB | Adobe PDF | View/Open |
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