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
| Autor: | Bernabeu Wittel, Máximo, Aparicio, Reyes, Romero, Manuel, Murcia Zaragoza, José, Monte Secades, Rafael, Rosso, Clara, Montero Saez, Abelardo, Ruiz Cantero, Alberto, Melero Bascones, María, PAHFRAC-01 investigators |
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| Předmět: |
Male
lcsh:Diseases of the musculoskeletal system Ferric Compounds Hip fracture law.invention Study Protocol Randomized controlled trial Quality of life law Orthopedics and Sports Medicine Hip joint Aged 80 and over Blood transfusion Anemia Combined Modality Therapy Red-cell pack Clinical trial Treatment Outcome Research Design Articulació coxofemoral Drug Therapy Combination Female Erythrocyte Transfusion medicine.drug medicine.medical_specialty Postoperative Hemorrhage Placebo Blood-saving strategies Double-Blind Method Rheumatology medicine Humans Maltose Transfusió de sang Erythropoietin Aged Intention-to-treat analysis Hip Fractures business.industry Transfusion Perioperative Ferric carboxymaltose medicine.disease Surgery lcsh:RC925-935 business Fractures Osteoporotic Fractures |
| Zdroj: | Recercat. Dipósit de la Recerca de Catalunya instname BMC Musculoskeletal Disorders, Vol 13, Iss 1, p 27 (2012) Dipòsit Digital de la UB Universidad de Barcelona BMC Musculoskeletal Disorders |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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