Efficacy of Ferric Carboxymaltose With or Without EPO Reducing Red-cell Transfusion Packs in Hip Fracture Perioperative Period

Phase 3

Completed

• Conditions: Hip Fractures
• Interventions: Drug: Placebo; Drug: Ferric carboxymaltose; Drug: Erythropoietin

• Registration Number: NCT01154491
• Lead Sponsor: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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.

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-06-24
• Study First Submitted QC: 2010-06-30
• Study First Posted: 2010-07-01
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 303

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Two placebos: placebo for ferric carboxymaltose and placebo for erythropoietin
FE	Ferric carboxymaltose	Ferric carboxymaltose and placebo for erythropoietin
EPOFE	Erythropoietin	Ferric carboxymaltose and erythropoietin
EPOFE	Ferric carboxymaltose	Ferric carboxymaltose and erythropoietin

Primary Outcome Measures

Name	Time	Method
Reduce red-cell transfusion packs	60 days after hospital discharge	percentage of patients who receive red-cell transfusion during hospitalization

Secondary Outcome Measures

Name	Time	Method
Average red-cell packs per patient	end of study
Haemoglobin level	24 h and 72h after the intervention, at the time of hospital discharge and 60 days after hospital discharge
Number of hospitalization days	end of study	number of days inhospital
Death rate with all causes mortality	end of study
Adverse Events	end of study	adverse clinical events, side effects, Serious Adverse Events (SAE) and Suspected Unexpected Serious Adverse Reaction(SUSAR)
Quality of life	end of study	health related quality of life
cost-efficacy analysis	end of study	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)

Trial Locations

Locations (14)

Hospital de la Vega Baja; 🇪🇸 Orihuela, Alicante, Spain

Hospital Universitario de Bellvitge; 🇪🇸 Hospitalet de Llobregat, Barcelona, Spain

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital General Universitario de Elche; 🇪🇸 Elche, Alicante, Spain

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, España, Spain

Hospital Donostia; 🇪🇸 San Sebastián, Guipúzcoa, Spain

Hospital de la Serranía de Ronda; 🇪🇸 Ronda, Malaga, Spain

Hospital Comarcal de la Axarquía; 🇪🇸 Vélez-Málaga, Málaga, Spain

Hospital Universitario de Albacete; 🇪🇸 Albacete, Spain

Hospital San Juan de Dios del Aljarafe; 🇪🇸 Bormujos, Sevilla, Spain

Hospital Infanta Elena; 🇪🇸 Huelva, Spain

Hospital Lucus Augusti; 🇪🇸 Lugo, Spain

Hospital Universitario Virgen Macarena; 🇪🇸 Seville, Spain

Hospital Universitario Río Hortega; 🇪🇸 Valladolid, Spain