Open Access Study protocol

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

Máximo Bernabeu-Wittel19*, Reyes Aparicio2, Manuel Romero3, José Murcia-Zaragoza4, Rafael Monte-Secades5, Clara Rosso1, Abelardo Montero6, Alberto Ruiz-Cantero7, María Melero-Bascones8 and PAHFRAC-01 investigators

Author Affiliations

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

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BMC Musculoskeletal Disorders 2012, 13:27  doi:10.1186/1471-2474-13-27

Published: 21 February 2012

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.

Keywords:
Hip fracture; Transfusion; Blood-saving strategies; Ferric carboxymaltose; Erythropoietin; Red-cell pack; Clinical trial