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-Wittel, Reyes Aparicio, Manuel Romero, José Murcia-Zaragoza, Rafael Monte-Secades, Clara Rosso, Abelardo Montero, Alberto Ruiz-Cantero, María Melero-Bascones, PAHFRAC-01 investigators, Máximo Bernabeu-Wittel, Mercedes Galván Banqueri, Maria Dolores Vega Coca, Francisco Javier Galindo Ocaña, Ricardo Parra Alcaraz, Manuel Rincón Gómez, María del Val Martín Sanz, Miguel Ángel Giráldez Sánchez, Manuel Anaya Rojas, Larbi Lezama Núñez, Manuel Ollero-Baturone, Javier Bautista Paloma, Bernardo Santos Ramos, Reyes Aparicio Santos, Ricardo Espinosa Calleja, Boris García Benítez, Abelardo Montero Sáez, Alberto Ruiz Cantero, José Luis Ruiz Arranz, José Murcia Zaragoza, Javier Santesmases Ejarque, Manuel Jesús Romero Jiménez, Miguel Ángel Pérez Ramos, Miguel Ángel Pascual Díaz, María Melero Bascones, Teresa Ros, Rafael Monte Secades, María Guil García, Máximo Bernabeu-Wittel, Reyes Aparicio, Manuel Romero, José Murcia-Zaragoza, Rafael Monte-Secades, Clara Rosso, Abelardo Montero, Alberto Ruiz-Cantero, María Melero-Bascones, PAHFRAC-01 investigators, Máximo Bernabeu-Wittel, Mercedes Galván Banqueri, Maria Dolores Vega Coca, Francisco Javier Galindo Ocaña, Ricardo Parra Alcaraz, Manuel Rincón Gómez, María del Val Martín Sanz, Miguel Ángel Giráldez Sánchez, Manuel Anaya Rojas, Larbi Lezama Núñez, Manuel Ollero-Baturone, Javier Bautista Paloma, Bernardo Santos Ramos, Reyes Aparicio Santos, Ricardo Espinosa Calleja, Boris García Benítez, Abelardo Montero Sáez, Alberto Ruiz Cantero, José Luis Ruiz Arranz, José Murcia Zaragoza, Javier Santesmases Ejarque, Manuel Jesús Romero Jiménez, Miguel Ángel Pérez Ramos, Miguel Ángel Pascual Díaz, María Melero Bascones, Teresa Ros, Rafael Monte Secades, María Guil García

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.

Figures

Figure 1
Figure 1
Scheme of the clinical trial visits in the three arms. V0 = Visit 0; S = Surgery; V1 = Visit 1 (24 hours after surgery); V2 = Visit 2 (72 hours after surgery); V3 = Visit 3 (the day of hospital discharge); V4 = Visit 4 (60 days after hospital discharge). A = Ferric carboximaltose + Erythropoietin; B = Ferric carboximaltose + Placebo; C = Placebo + Placebo

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Source: PubMed

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