Cross Iron (Comparative Randomized Oral Versus Systemic IRON) (Cross Iron)

January 21, 2019 updated by: University Hospital, Montpellier

Comparison of Preoperative Haemoglobin Level After Administration of Epoetin Alfa Associated With an Oral Versus Intravenous Iron Supplementation

Patients were recruited at the scheduled preoperative visit for hip or knee arthroplasty. If the haemoglobin (Hb) level was below 13 g/dl with no contraindication to iron supplementation the patients were randomized to the oral or intravenous (IV) group. The oral group received 160 mg ferrous glycine sulfate daily during the month prior surgery, associated with 3 epoetin alpha (EPO) injections (40 000 IU subcutaneous on day - 21, day - 14 and day-7). The IV group received ferric carboxymaltose 1000 mg IV in 15 minutes one month before surgery, associated with 3 EPO injections. Primary efficacy endpoint was the change in Hb level from the day of the preoperative visit to the day before surgery (day-1). Secondary endpoints comprised the Hb level on day 3 and 5 after surgery, allogenic transfusion during and after surgery, and the change in iron indices from the day of the preoperative visit to day - 1.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Hôpital Lapeyronie - Département Anesthésie Réanimation A

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

  • unilateral prothetic orthopaedic surgery scheduled
  • age > 18
  • weight > 50 kg
  • hemoglobin rate: 10 g/dl ≤ Hb <13 g/dl

Exclusion criteria:

  • bilateral arthroplasty
  • EPO contraindication
  • generalized infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1: Per Os Tardyferon
EPO associated with Iron per os tardyferon before surgery. The oral group received 160 mg ferrous glycine sulfate daily during the month prior surgery, associated with 3 epoetin alpha (EPO) injections (40 000 IU subcutaneous on day - 21, day - 14 and day-7).
Drug: Epoetin Alfa
Drug: ferrous glycine sulfate Tardyferon
Experimental: Group 2: IV Ferinject
EPO associated with Iron per IV Ferinject before surgery. The IV group received ferric carboxymaltose 1000 mg IV in 15 minutes one month before surgery, associated with 3 EPO injections.
Drug: Epoetin Alfa
Drug: ferric carboxymaltose Ferinject

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Compare Hb level after treatment with EPO associated with iron treatment by oral or intravenous route
Time Frame: the day before surgery (day - 1)
the day before surgery (day - 1)

Secondary Outcome Measures

Outcome Measure
Time Frame
Hb level
Time Frame: before iron treatment, then the day before surgery (day - 1) based on reference iron balance
before iron treatment, then the day before surgery (day - 1) based on reference iron balance
number of red blood cells
Time Frame: during surgery and 3 days after surgery
during surgery and 3 days after surgery
the change in iron indices
Time Frame: before iron treatment and after iron treatment the day before surgery (day - 1)
before iron treatment and after iron treatment the day before surgery (day - 1)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Philippe BIBOULET, MD, PhD, Montpellier University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2014

Primary Completion (Actual)

October 16, 2016

Study Completion (Actual)

October 16, 2016

Study Registration Dates

First Submitted

June 19, 2015

First Submitted That Met QC Criteria

July 9, 2015

First Posted (Estimate)

July 14, 2015

Study Record Updates

Last Update Posted (Actual)

January 23, 2019

Last Update Submitted That Met QC Criteria

January 21, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9408
  • 2014-A00642-45 (Registry Identifier: ID RCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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