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Hip FracturesPhase 3PAHFRACNCT01154491

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

A Phase 3 study testing Ferric carboxymaltose and Erythropoietin in people with Hip Fractures, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 14 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Hip Fractures
What is being tested?
Ferric carboxymaltose and Erythropoietin
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
303 participants
Where
14 sitesSpain
Study dates
Jun 2010to May 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Patients 65 years and older.
  • Osteoporotic hip fracture which require surgical intervention
  • Haemoglobin levels between 90-120 g/L
  • Signed informed consent form

Who cannot join

  • 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.

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Spain14 sites

  • Hospital Universitario de Albacete

    Albacete, Albacete, 02006

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08915

  • Hospital San Juan de Dios del Aljarafe

    Bormujos, Sevilla, 41930

  • Hospital General Universitario de Elche

    Elche, Alicante

  • Hospital Infanta Elena

    Huelva, Huelva, 21080

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Lucus Augusti

    Lugo, Lugo, 27004

  • Hospital de la Vega Baja

    Orihuela, Alicante, 03314

  • Hospital de la Serranía de Ronda

    Ronda, Malaga, 29400

  • Hospital Donostia

    San Sebastián, Guipúzcoa

  • Hospital Universitario Virgen del Rocío

    Seville, España, 41013

  • Hospital Universitario Virgen Macarena

    Seville, Seville

  • Hospital Universitario Río Hortega

    Valladolid

  • Hospital Comarcal de la Axarquía

    Vélez-Málaga, Málaga

Other trials in Spain

About this study

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.

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.

Read the 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.

Conditions
Hip Fractures
Being tested
Ferric carboxymaltose, Erythropoietin, Placebo
Keywords
hip fractures, blood substitutes, blood transfusion, intravenous infusion, erythropoietin, recombinant, frail elderly
Medical subject headings
Hip Fractures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ferric carboxymaltoseDrug

    Also called Intravenous iron

    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.

  • ErythropoietinDrug

    Also called EPO

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

  • PlaceboDrug

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

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

Study groups in NCT01154491
Study groupRoleWhat they receive
PlaceboPlacebo comparatorTwo placebos: placebo for ferric carboxymaltose and placebo for erythropoietin
Receives: Drug: Placebo
FEExperimentalFerric carboxymaltose and placebo for erythropoietin
Receives: Drug: Ferric carboxymaltose
EPOFEExperimentalFerric carboxymaltose and erythropoietin
Receives: Drug: Ferric carboxymaltose; Drug: Erythropoietin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduce red-cell transfusion packs

    percentage of patients who receive red-cell transfusion during hospitalization

    Measured: 60 days after hospital discharge

Secondary outcomes (7)

  1. Average red-cell packs per patient

    Measured: end of study

  2. Haemoglobin level

    Measured: 24 h and 72h after the intervention, at the time of hospital discharge and 60 days after hospital discharge

  3. Number of hospitalization days

    number of days inhospital

    Measured: end of study

  4. Death rate with all causes mortality

    Measured: end of study

  5. Adverse Events

    adverse clinical events, side effects, Serious Adverse Events (SAE) and Suspected Unexpected Serious Adverse Reaction(SUSAR)

    Measured: end of study

  6. Quality of life

    health related quality of life

    Measured: end of study

  7. 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)

    Measured: end of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2010 (estimated)
  2. Study startJun 2010
  3. Primary completionMay 2013
  4. Study completionMay 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
303 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01154491
Sponsor's protocol ID
PAHFRAC-01
Other IDs
2009-015865-30, 2009
Acronym
PAHFRAC
Status last verified
Jul 2015
First submitted
24 Jun 2010
Last updated
28 Jul 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 27195774

  • 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.

    PubMed 22353604

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ferric carboxymaltose and Erythropoietin in people with Hip Fractures, run by Fundación Pública Andaluza para la gestión de la Investigación en Sevilla at 14 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduce red-cell transfusion packs (time frame: 60 days after hospital discharge). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01154491, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2015.

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