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

NCT01154491 | Completed Phase 3

• 2 other identifiers: PAHFRAC-012009-015865-30
• Study Type: interventional
• Target: 303
• Locations: 1 country
• Sites: 14

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.

Conditions

Hip Fractures

Keywords

hip fractures; blood substitutes; blood transfusion; intravenous infusion; erythropoietin, recombinant; frail elderly

Outcome Measures

Primary Outcomes (1)

• Reduce red-cell transfusion packs

  percentage of patients who receive red-cell transfusion during hospitalization

  60 days after hospital discharge

Secondary Outcomes (7)

• 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

• Death rate with all causes mortality

  end of study

• Adverse Events

  end of study

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Two placebos: placebo for ferric carboxymaltose and placebo for erythropoietin

Drug: Placebo

FE

EXPERIMENTAL

Ferric carboxymaltose and placebo for erythropoietin

Drug: Ferric carboxymaltose

EPOFE

EXPERIMENTAL

Ferric carboxymaltose and erythropoietin

Drug: Ferric carboxymaltose; Drug: Erythropoietin

Interventions

Ferric carboxymaltose 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.

Also known as: Intravenous iron

EPOFE; FE

Erythropoietin DRUG

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

Also known as: EPO

EPOFE

Placebo DRUG

Placebo for ferric carboxymaltose: 250 mL normal saline for intravenous administration. Placebo for erythropoietin: 1 mL normal saline for subcutaneous injection.

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: lead

Study Sites (14)

Hospital Universitario de Albacete

Albacete, Albacete, 02006, Spain

Location

Hospital General Universitario de Elche

Elche, Alicante, Spain

Location

Hospital de la Vega Baja

Orihuela, Alicante, 03314, Spain

Location

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08915, Spain

Location

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, España, 41013, Spain

Location

Hospital Donostia

San Sebastián, Guipúzcoa, Spain

Location

Hospital Infanta Elena

Huelva, Huelva, 21080, Spain

Location

Hospital Lucus Augusti

Lugo, Lugo, 27004, Spain

Location

Hospital de la Serranía de Ronda

Ronda, Malaga, 29400, Spain

Location

Hospital Comarcal de la Axarquía

Vélez-Málaga, Málaga, Spain

Location

Hospital San Juan de Dios del Aljarafe

Bormujos, Sevilla, 41930, Spain

Location

Hospital Universitario Virgen Macarena

Seville, Seville, Spain

Location

Hospital Universitario Río Hortega

Valladolid, Spain

Location

Related Publications (2)

• 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.

  PMID: 27195774 DERIVED

• 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.

  PMID: 22353604 DERIVED

MeSH Terms

Conditions

Hip Fractures

Interventions

ferric carboxymaltose; Erythropoietin

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Máximo Bernabeu-Wittel, MD

  Hospital Universitario Virgen del Rocio. Sevilla

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Maximo Bernabeu Wittel

Study Record Dates

• First Submitted: June 24, 2010
• First Posted: July 1, 2010
• Study Start: June 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: July 28, 2015

Record last verified: 2015-07

Locations

ES (14)