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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-015865-30 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Two placebos: placebo for ferric carboxymaltose and placebo for erythropoietin |
|
| FE | Experimental | Ferric carboxymaltose and placebo for erythropoietin |
|
| EPOFE | Experimental | Ferric carboxymaltose and erythropoietin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduce red-cell transfusion packs | percentage of patients who receive red-cell transfusion during hospitalization | 60 days after hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Average red-cell packs per patient | end of study | |
| Haemoglobin level | 24 h and 72h after the intervention, at the time of hospital discharge and 60 days after hospital discharge | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Máximo Bernabeu-Wittel, MD | Hospital Universitario Virgen del Rocio. Sevilla | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de Albacete | Albacete | Albacete | 02006 | Spain | ||
| Hospital General Universitario de Elche |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27195774 | Derived | Bernabeu-Wittel M, Romero M, Ollero-Baturone M, Aparicio R, Murcia-Zaragoza J, Rincon-Gomez 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. | |
| 22353604 |
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|
|
| Erythropoietin | Drug | Erythropoetin: 40,000 units subcutaneous (unique dose). |
|
|
| Placebo | Drug | Placebo for ferric carboxymaltose: 250 mL normal saline for intravenous administration. Placebo for erythropoietin: 1 mL normal saline for subcutaneous injection. |
|
| Number of hospitalization days |
number of days inhospital |
| end of study |
| Death rate with all causes mortality | end of study |
| Adverse Events | adverse clinical events, side effects, Serious Adverse Events (SAE) and Suspected Unexpected Serious Adverse Reaction(SUSAR) | end of study |
| Quality of life | health related quality of life | end of study |
| 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 |
| Elche |
| Alicante |
| Spain |
| Hospital de la Vega Baja | Orihuela | Alicante | 03314 | Spain |
| Hospital Germans Trias i Pujol | Badalona | Barcelona | 08915 | Spain |
| Hospital Universitario de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital Universitario Virgen del Rocío | Seville | España | 41013 | Spain |
| Hospital Donostia | San Sebastián | Guipúzcoa | Spain |
| Hospital Infanta Elena | Huelva | Huelva | 21080 | Spain |
| Hospital Lucus Augusti | Lugo | Lugo | 27004 | Spain |
| Hospital de la Serranía de Ronda | Ronda | Malaga | 29400 | Spain |
| Hospital Comarcal de la Axarquía | Vélez-Málaga | Málaga | Spain |
| Hospital San Juan de Dios del Aljarafe | Bormujos | Sevilla | 41930 | Spain |
| Hospital Universitario Virgen Macarena | Seville | Seville | Spain |
| Hospital Universitario Río Hortega | Valladolid | Spain |
| Derived |
| 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. |
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
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| ID | Term |
|---|---|
| C522335 | ferric carboxymaltose |
| D004921 | Erythropoietin |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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