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

Hip Fractures Clinical Trial

— PAHFRAC  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01154491
• Other study ID #: PAHFRAC-01
• Secondary ID: 2009-015865-30
• Status: Completed
• Phase: Phase 3
• First received: June 24, 2010
• Last updated: July 27, 2015
• Start date: June 2010
• Est. completion date: May 2013

Study information

• Verified date: July 2015
• Source: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fractures, Bone
• Hip Fractures

Intervention

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.
• Erythropoietin
Erythropoetin: 40,000 units subcutaneous (unique dose).
• Placebo
Placebo for ferric carboxymaltose: 250 mL normal saline for intravenous administration. Placebo for erythropoietin: 1 mL normal saline for subcutaneous injection.

Locations

Country	Name	City	State
Spain	Hospital Universitario de Albacete	Albacete
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital San Juan de Dios del Aljarafe	Bormujos	Sevilla
Spain	Hospital General Universitario de Elche	Elche	Alicante
Spain	Hospital Universitario de Bellvitge	Hospitalet de Llobregat	Barcelona
Spain	Hospital Infanta Elena	Huelva
Spain	Hospital Lucus Augusti	Lugo
Spain	Hospital de la Vega Baja	Orihuela	Alicante
Spain	Hospital de la Serranía de Ronda	Ronda	Malaga
Spain	Hospital Donostia	San Sebastián	Guipúzcoa
Spain	Hospital Universitario Virgen del Rocío	Sevilla	España
Spain	Hospital Universitario Virgen Macarena	Seville
Spain	Hospital Universitario Río Hortega	Valladolid
Spain	Hospital Comarcal de la Axarquía	Vélez-Málaga	Málaga

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduce red-cell transfusion packs	percentage of patients who receive red-cell transfusion during hospitalization	60 days after hospital discharge	No
Secondary	Average red-cell packs per patient		end of study	No
Secondary	Haemoglobin level		24 h and 72h after the intervention, at the time of hospital discharge and 60 days after hospital discharge	No
Secondary	Number of hospitalization days	number of days inhospital	end of study	No
Secondary	Death rate with all causes mortality		end of study	Yes
Secondary	Adverse Events	adverse clinical events, side effects, Serious Adverse Events (SAE) and Suspected Unexpected Serious Adverse Reaction(SUSAR)	end of study	Yes
Secondary	Quality of life	health related quality of life	end of study	No
Secondary	cost-efficacy analysis	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)	end of study	No