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NCT Number: NCT01154491

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

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.

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Key information

Conditions

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

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Universitario de Albacete, Albacete, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Intravenous iron

Erythropoietin

Drug

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

Other names: EPO

Placebo

Drug

Placebo for ferric carboxymaltose: 250 mL normal saline for intravenous administration.

Placebo for erythropoietin: 1 mL normal saline for subcutaneous injection.

Primary outcomes

  1. Reduce red-cell transfusion packs

    Time frame: 60 days after hospital discharge

    percentage of patients who receive red-cell transfusion during hospitalization

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Other

Registry information

Official study 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.

Acronym: PAHFRAC

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 1, 2010
Registry last updated
Jul 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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