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Completed

NCT Number: NCT02496377

Cross Iron (Comparative Randomized Oral Versus Systemic IRON)

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.

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Key information

Conditions

Allogenic Transfusion Anemia Hematologic Diseases Hemic and Lymphatic Diseases Hip Arthroplasty Iron Deficiencies Iron Metabolism Disorders Knee Arthroplasty Metabolic Diseases Nutritional and Metabolic Diseases Perioperative Anaemia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Lapeyronie - Département Anesthésie Réanimation A

Montpellier, 34295, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ferrous glycine sulfate Tardyferon

Drug

Epoetin alfa

Drug

ferric carboxymaltose Ferinject

Drug

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: Cross Iron

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jul 14, 2015
Registry last updated
Jan 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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