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

This study is currently recruiting participants.
Verified January 2013 by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Sponsor:
Information provided by (Responsible Party):
Maximo Bernabeu Wittel, Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
ClinicalTrials.gov Identifier:
NCT01154491
First received: June 24, 2010
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
  Purpose

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 48 and 96 h of intervention, haemoglobin at 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 Intervention Phase
Hip Fractures
 Drug: Ferric carboxymaltose
Drug: Erythropoietin
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:

Primary Outcome Measures:
  • Reduce red-cell transfusion packs [ Time Frame: 60 days after hospital discharge ] [ Designated as safety issue: No ]
    percentage of patients who receive red-cell transfusion during hospitalization


Secondary Outcome Measures:
  • Average red-cell packs per patient [ Time Frame: end of study ] [ Designated as safety issue: No ]
  • Haemoglobin level [ Time Frame: end of study ] [ Designated as safety issue: No ]
  • Number of hospitalization days [ Time Frame: end of study ] [ Designated as safety issue: No ]
    number of days inhospital

  • Death rate with all causes mortality [ Time Frame: end of study ] [ Designated as safety issue: Yes ]
  • Adverse Events [ Time Frame: end of study ] [ Designated as safety issue: Yes ]
    adverse clinical events, side effects, Serious Adverse Events (SAE) and Suspected Unexpected Serious Adverse Reaction(SUSAR)

  • Quality of life [ Time Frame: end of study ] [ Designated as safety issue: No ]
    health related quality of life

  • cost-efficacy analysis [ Time Frame: end of study ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 306
Study Start Date: June 2010
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Other Name: Placebo
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

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01154491

Contacts
Contact: Clara M Rosso, MD 955013414 claram.rosso.sspa@juntadeandalucia.es

Locations
Spain
Hospital General Universitario de Elche Recruiting
Elche, Alicante, Spain
Principal Investigator: Antonia Mora Rufete, PhD            
Hospital de la Vega Baja Recruiting
Orihuela, Alicante, Spain, 03314
Principal Investigator: J. Manuel Murcia-Zaragoza, MD            
Hospital Germans Trias i Pujol Terminated
Badalona, Barcelona, Spain, 08915
Hospital Universitario de Bellvitge Recruiting
Hospitalet de Llobregat, Barcelona, Spain, 08907
Principal Investigator: Abelardo Montero-Saez, MD            
Hospital Universitario Virgen del Rocío Recruiting
Sevilla, España, Spain, 41013
Principal Investigator: Maximo Bernabeu-Wittel, PhD            
Hospital Donostia Recruiting
San Sebastián, Guipúzcoa, Spain
Principal Investigator: Fátima Almagro Múgica, MD            
Hospital de la Serranía de Ronda Recruiting
Ronda, Malaga, Spain, 29400
Principal Investigator: Alberto Ruiz-Cantero, MD            
Hospital Comarcal de la Axarquía Recruiting
Vélez-Málaga, Málaga, Spain
Principal Investigator: María Guil García, Dra.            
Hospital San Juan de Dios del Aljarafe Recruiting
Bormujos, Sevilla, Spain, 41930
Principal Investigator: Reyes Aparicio-Santos, MD            
Sub-Investigator: Ricardo Espinosa Calleja, MD            
Hospital Universitario de Albacete Recruiting
Albacete, Spain, 02006
Principal Investigator: María Melero-Bascones, MD            
Hospital Infanta Elena Recruiting
Huelva, Spain, 21080
Principal Investigator: Manuel Romero-Jiménez, MD            
Hospital Lucus Augusti Recruiting
Lugo, Spain, 27004
Principal Investigator: Rafael Monte-Secades, MD            
Hospital Universitario Central de Asturias Recruiting
Oviedo, Spain
Principal Investigator: Alejandro Braña Vigil, MD            
Hospital Universitario Virgen Macarena Recruiting
Seville, Spain
Contact: Fernando Garrachón Vallo, MD            
Principal Investigator: Fernando Garrachón Vallo, PhD            
Hospital Universitario Río Hortega Recruiting
Valladolid, Spain
Principal Investigator: Laura Abad Manteca, MD            
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

No publications provided by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

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

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
Study First Received: June 24, 2010
Last Updated: January 3, 2013
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by 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
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013