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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Hip Fractures	Drug: Ferric carboxymaltose; Drug: Erythropoietin; Drug: Placebo	Phase 3

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	303 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:	Treatment
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 Start Date :	June 2010
Actual Primary Completion Date :	May 2013
Actual Study Completion Date :	May 2013

Arms and Interventions

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Arm	Intervention/treatment
Placebo Comparator: Placebo; Two placebos: placebo for ferric carboxymaltose and placebo for erythropoietin	Drug: Placebo; Placebo for ferric carboxymaltose: 250 mL normal saline for intravenous administration. Placebo for erythropoietin: 1 mL normal saline for subcutaneous injection.
Experimental: FE; Ferric carboxymaltose and placebo for erythropoietin	Drug: 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.; Other Name: Intravenous iron
Experimental: EPOFE; Ferric carboxymaltose and erythropoietin	Drug: 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.; Other Name: Intravenous iron Drug: Erythropoietin; Erythropoetin: 40,000 units subcutaneous (unique dose).; Other Name: EPO

Outcome Measures

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Primary Outcome Measures :

1. Reduce red-cell transfusion packs [ Time Frame: 60 days after hospital discharge ]
   percentage of patients who receive red-cell transfusion during hospitalization

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	65 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Locations

Spain
Hospital General Universitario de Elche
Elche, Alicante, Spain
Hospital de la Vega Baja
Orihuela, Alicante, Spain, 03314
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08915
Hospital Universitario de Bellvitge
Hospitalet de Llobregat, Barcelona, Spain, 08907
Hospital Universitario Virgen del Rocío
Sevilla, España, Spain, 41013
Hospital Donostia
San Sebastián, Guipúzcoa, Spain
Hospital de la Serranía de Ronda
Ronda, Malaga, Spain, 29400
Hospital Comarcal de la Axarquía
Vélez-Málaga, Málaga, Spain
Hospital San Juan de Dios del Aljarafe
Bormujos, Sevilla, Spain, 41930
Hospital Universitario de Albacete
Albacete, Spain, 02006
Hospital Infanta Elena
Huelva, Spain, 21080
Hospital Lucus Augusti
Lugo, Spain, 27004
Hospital Universitario Virgen Macarena
Seville, Spain
Hospital Universitario Río Hortega
Valladolid, Spain

Sponsors and Collaborators

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Investigators

Principal Investigator:	Máximo Bernabeu-Wittel, MD	Hospital Universitario Virgen del Rocio. Sevilla

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bernabeu-Wittel M, Romero M, Ollero-Baturone M, Aparicio R, Murcia-Zaragoza J, Rincón-Gómez 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.

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.

Responsible Party:	Maximo Bernabeu Wittel, Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier:	NCT01154491 History of Changes
Other Study ID Numbers:	PAHFRAC-01; 2009-015865-30 ( EudraCT Number )
First Posted:	July 1, 2010
Last Update Posted:	July 28, 2015
Last Verified:	July 2015

Keywords provided by Maximo Bernabeu Wittel, Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:

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

Additional relevant MeSH terms:

Fractures, Bone; Hip Fractures; Wounds and Injuries; Femoral Fractures; Hip Injuries	Leg Injuries; Epoetin Alfa; Ferric Compounds; Hematinics