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

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:

MedlinePlus related topics: Blood Transfusion and Donation Fractures Hip Injuries and Disorders

Drug Information available for: Ferric carboxymaltose Erythropoietin Epoetin Alfa

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)


Enrollment:	303
Study Start Date:	June 2010
Study Completion Date:	May 2013
Primary Completion Date:	May 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01154491

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

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):

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
Study First Received:	June 24, 2010
Last Updated:	October 9, 2014
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 Femoral Fractures Hip Injuries Leg Injuries Wounds and Injuries	Epoetin alfa Ferric Compounds Hematinics Hematologic Agents Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 02, 2015

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