Efficacy of Ferric Carboxymaltose With or Without EPO Reducing Red-cell Transfusion Packs in Hip Fracture Perioperative Period (PAHFRAC)
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| ClinicalTrials.gov Identifier: NCT01154491 |
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Recruitment Status :
Completed
First Posted : July 1, 2010
Last Update Posted : July 28, 2015
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Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Information provided by (Responsible Party):
Maximo Bernabeu Wittel, Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hip Fractures | Drug: Ferric carboxymaltose Drug: Erythropoietin Drug: Placebo | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 303 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, 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. |
| Study Start Date : | June 2010 |
| Actual Primary Completion Date : | May 2013 |
| Actual Study Completion Date : | May 2013 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Placebo Comparator: Placebo
Two placebos: placebo for ferric carboxymaltose and placebo for erythropoietin
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Drug: Placebo
Placebo for ferric carboxymaltose: 250 mL normal saline for intravenous administration. Placebo for erythropoietin: 1 mL normal saline for subcutaneous injection. |
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Experimental: FE
Ferric carboxymaltose and placebo for erythropoietin
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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 |
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Experimental: EPOFE
Ferric carboxymaltose and erythropoietin
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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 |
Primary Outcome Measures :
- Reduce red-cell transfusion packs [ Time Frame: 60 days after hospital discharge ]percentage of patients who receive red-cell transfusion during hospitalization
Secondary Outcome Measures :
- Average red-cell packs per patient [ Time Frame: end of study ]
- Haemoglobin level [ Time Frame: 24 h and 72h after the intervention, at the time of hospital discharge and 60 days after hospital discharge ]
- Number of hospitalization days [ Time Frame: end of study ]number of days inhospital
- Death rate with all causes mortality [ Time Frame: end of study ]
- Adverse Events [ Time Frame: end of study ]adverse clinical events, side effects, Serious Adverse Events (SAE) and Suspected Unexpected Serious Adverse Reaction(SUSAR)
- Quality of life [ Time Frame: end of study ]health related quality of life
- 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)
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| Ages Eligible for Study: | 65 Years and older (Older Adult) |
| Sexes Eligible for Study: | All |
| 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
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 ( EudraCT Number ) |
| First Posted: | July 1, 2010 Key Record Dates |
| Last Update Posted: | July 28, 2015 |
| Last Verified: | July 2015 |
Keywords provided by Maximo Bernabeu Wittel, Fundación Pública Andaluza para la gestión de la Investigación en Sevilla:
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hip fractures blood substitutes blood transfusion |
intravenous infusion erythropoietin, recombinant frail elderly |
Additional relevant MeSH terms:
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Fractures, Bone Hip Fractures Wounds and Injuries Femoral Fractures Hip Injuries |
Leg Injuries Epoetin Alfa Ferric Compounds Hematinics |