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Trial record 30 of 46 for:    FERRIC SULFATE

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

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ClinicalTrials.gov Identifier: NCT02496377
Recruitment Status : Completed
First Posted : July 14, 2015
Last Update Posted : January 23, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Allogenic Transfusion Perioperative Anaemia Knee Arthroplasty Hip Arthroplasty Drug: ferrous glycine sulfate Tardyferon Drug: Epoetin Alfa Drug: ferric carboxymaltose Ferinject Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Other
Official Title: Comparison of Preoperative Haemoglobin Level After Administration of Epoetin Alfa Associated With an Oral Versus Intravenous Iron Supplementation
Actual Study Start Date : August 29, 2014
Actual Primary Completion Date : October 16, 2016
Actual Study Completion Date : October 16, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

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: ferrous glycine sulfate Tardyferon
Drug: Epoetin Alfa
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



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

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


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02496377


Locations
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France
Hôpital Lapeyronie - Département Anesthésie Réanimation A
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
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Principal Investigator: Philippe BIBOULET, MD, PhD Montpellier University Hospital

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Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02496377     History of Changes
Other Study ID Numbers: 9408
2014-A00642-45 ( Registry Identifier: ID RCB )
First Posted: July 14, 2015    Key Record Dates
Last Update Posted: January 23, 2019
Last Verified: January 2019

Keywords provided by University Hospital, Montpellier:
Anaemia
Iron deficiency
Ferric carboxymaltose
Patient blood management
Hip arthroplasty
Knee arthroplasty

Additional relevant MeSH terms:
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Ferric Compounds
Iron
Epoetin Alfa
Glycine
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hematinics
Glycine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action