Clinical trial NCT01154491: Efficacy of Ferric Carboxymaltose With or Without EPO Reducing Red-cell Transfusion Packs in Hip Fracture Perioperative Period
Official title: Multicenter Double-bind Randomized Trial of Ferric Carboxymaltose With or Without Erythropoietin for the Prevention of Red-cell Transfusion in Hip Fracture Perioperative Period.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hip Fractures
Keywords: hip fractures
blood substitutes
blood transfusion
intravenous infusion
erythropoietin, recombinant
frail elderly
Lead sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor class: OTHER
First posted: 2010-07-01
Enrollment: 303
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In order to evaluate the efficacy of ferric carboxymaltose + erythropoietin versus ferric carboxymaltose versus placebo in reducing the percentage of patients who receive red-cell transfusion in the perioperative period of hip fracture, a multicenter, randomized, parallel groups, double-blind clinical trial in adult patients admitted for osteoporotic hip fracture is designed. Required sample size is of 87 patients per arm (87x3 = 261). Primary efficacy variable is the percentage of patients who receive red-cell transfusion during hospitalization; secondary end-points: average red-cell packs per patient,haemoglobin at 24 h and 72h after the intervention, at the time of hospital discharge and 60 days after hospital discharge, hospital stay and mortality during hospital-stay and 60 days afterwards. Adverse clinical events and side effects are assessed as safety variables. In addition health related quality of life will be measured at inclusion and after 60 days. A cost-efficacy analysis (by means of incremental cost-efficacy method using as a primary endpoint each patient not requiring transfusion, and as secondary end-point every patient who survived the index admission is performed). The investigators would like to demonstrate a double benefits: optimizing precious resource such as blood products and reducing complications arising from their use.

Detailed description: Three arms of treatments: A: ferric carboxymaltose and erythropoietin, B: ferric carboxymaltose and placebo, arm C: two placebos. Primary objective:reduction of red-cell packs needed for elderly patients with osteoporotic hip fracture which requires surgical intervention in the perioperative period.

Eligibility criteria: Inclusion Criteria:

* Patients 65 years and older.
* Osteoporotic hip fracture which require surgical intervention
* Haemoglobin levels between 90-120 g/L
* Signed informed consent form

Exclusion Criteria:

* Bone marrow diseases which could interfere in the erythropoietic process (acute or chronic myelodysplastic syndromes or myeloproliferative diseases, and/or infiltration of the bone marrow due to solid or lymphatic neoplasms)
* Blood coagulation diseases or currently treated with oral anticoagulants and/or heparin at therapeutic doses.
* Documented allergy and/or previous intolerance and/or contraindication of erythropoietin use and/or intravenous iron.
* Patients with rheumatoid arthritis and/or another demonstrated origin of inflammatory anemia and/or not controlled arterial hypertension.

Primary outcomes:
measure: Reduce red-cell transfusion packs
timeFrame: 60 days after hospital discharge
Secondary outcomes:
measure: Average red-cell packs per patient
timeFrame: end of study
measure: Haemoglobin level
timeFrame: 24 h and 72h after the intervention, at the time of hospital discharge and 60 days after hospital discharge
measure: Number of hospitalization days
timeFrame: end of study
measure: Death rate with all causes mortality
timeFrame: end of study
measure: Adverse Events
timeFrame: end of study
measure: Quality of life
timeFrame: end of study
measure: cost-efficacy analysis
timeFrame: end of study
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
city: Orihuela
country: Spain
facility: Hospital de la Vega Baja
state: Alicante
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Universitario de Bellvitge
state: Barcelona
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
state: España
city: San Sebastián
country: Spain
facility: Hospital Donostia
state: Guipúzcoa
city: Ronda
country: Spain
facility: Hospital de la Serranía de Ronda
state: Malaga
city: Vélez-Málaga
country: Spain
facility: Hospital Comarcal de la Axarquía
state: Málaga
city: Bormujos
country: Spain
facility: Hospital San Juan de Dios del Aljarafe
state: Sevilla
city: Albacete
country: Spain
facility: Hospital Universitario de Albacete
city: Huelva
country: Spain
facility: Hospital Infanta Elena
city: Lugo
country: Spain
facility: Hospital Lucus Augusti
city: Seville
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Valladolid
country: Spain
facility: Hospital Universitario Río Hortega
Study officials:
affiliation: Hospital Universitario Virgen del Rocio. Sevilla
name: Máximo Bernabeu-Wittel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bernabeu-Wittel M, Romero M, Ollero-Baturone M, Aparicio R, Murcia-Zaragoza J, Rincon-Gomez M, Monte-Secades R, Melero-Bascones M, Rosso CM, Ruiz-Cantero A; PAHFRAC-01 Investigators. Ferric carboxymaltose with or without erythropoietin in anemic patients with hip fracture: a randomized clinical trial. Transfusion. 2016 Sep;56(9):2199-211. doi: 10.1111/trf.13624. Epub 2016 May 14.
citation: Bernabeu-Wittel M, Aparicio R, Romero M, Murcia-Zaragoza J, Monte-Secades R, Rosso C, Montero A, Ruiz-Cantero A, Melero-Bascones M; PAHFRAC-01 investigators. 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. BMC Musculoskelet Disord. 2012 Feb 21;13:27. doi: 10.1186/1471-2474-13-27.