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

NCT ID: NCT01154491

Last Updated: 2015-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 303 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2013-05-31

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.

Conditions

Hip Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Two placebos: placebo for ferric carboxymaltose and placebo for erythropoietin

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo for ferric carboxymaltose: 250 mL normal saline for intravenous administration.

Placebo for erythropoietin: 1 mL normal saline for subcutaneous injection.

FE

Ferric carboxymaltose and placebo for erythropoietin

Group Type: EXPERIMENTAL

Ferric carboxymaltose

Intervention Type: DRUG

Ferinject®: Ferric carboxymaltose: 2 vials of 10 mL containing each 500 mg iron, diluted in 250 mL normal saline for injection. Study drug to be administered by infusion immediately after preparation.

Placebo for erythropoietin: 1 mL normal saline for subcutaneous injection.

EPOFE

Ferric carboxymaltose and erythropoietin

Group Type: EXPERIMENTAL

Ferric carboxymaltose

Intervention Type: DRUG

Ferinject®: Ferric carboxymaltose: 2 vials of 10 mL containing each 500 mg iron, diluted in 250 mL normal saline for injection. Study drug to be administered by infusion immediately after preparation.

Placebo for erythropoietin: 1 mL normal saline for subcutaneous injection.

Erythropoietin

Intervention Type: DRUG

Erythropoetin: 40,000 units subcutaneous (unique dose).

Interventions

Ferric carboxymaltose

Ferinject®: Ferric carboxymaltose: 2 vials of 10 mL containing each 500 mg iron, diluted in 250 mL normal saline for injection. Study drug to be administered by infusion immediately after preparation.

Placebo for erythropoietin: 1 mL normal saline for subcutaneous injection.

Intervention Type: DRUG

Erythropoietin

Erythropoetin: 40,000 units subcutaneous (unique dose).

Intervention Type: DRUG

Placebo

Placebo for ferric carboxymaltose: 250 mL normal saline for intravenous administration.

Placebo for erythropoietin: 1 mL normal saline for subcutaneous injection.

Intervention Type: DRUG

Other Intervention Names

Intravenous iron; EPO

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER

Sponsor Role: lead

Responsible Party

Maximo Bernabeu Wittel

Maximo Bernabeu Wittel

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Máximo Bernabeu-Wittel, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Virgen del Rocio. Sevilla

Locations

Hospital Universitario de Albacete

Albacete, Albacete, Spain

Hospital General Universitario de Elche

Elche, Alicante, Spain

Hospital de la Vega Baja

Orihuela, Alicante, Spain

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Universitario Virgen del Rocío

Seville, España, Spain

Hospital Donostia

San Sebastián, Guipúzcoa, Spain

Hospital Infanta Elena

Huelva, Huelva, Spain

Hospital Lucus Augusti

Lugo, Lugo, Spain

Hospital de la Serranía de Ronda

Ronda, Malaga, Spain

Hospital Comarcal de la Axarquía

Vélez-Málaga, Málaga, Spain

Hospital San Juan de Dios del Aljarafe

Bormujos, Sevilla, Spain

Hospital Universitario Virgen Macarena

Seville, Seville, Spain

Hospital Universitario Río Hortega

Valladolid, , Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 27195774 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 22353604 (View on PubMed)

Other Identifiers

2009-015865-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

PAHFRAC-01

Identifier Type: -

Identifier Source: org_study_id