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

NCT01154491 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 303

Last updated 2015-07-28

No results posted yet for this study

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.

Conditions

  • Hip Fractures

Interventions

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.

DRUG

Erythropoietin

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

DRUG

Placebo

Placebo for ferric carboxymaltose: 250 mL normal saline for intravenous administration. Placebo for erythropoietin: 1 mL normal saline for subcutaneous injection.

Sponsors & Collaborators

  • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

    lead OTHER

Principal Investigators

  • Máximo Bernabeu-Wittel, MD · Hospital Universitario Virgen del Rocio. Sevilla

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2013-05-31
Completion
2013-05-31

Countries

  • Spain

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01154491 on ClinicalTrials.gov