Comparison of the Rate of Preoperative Haemoglobin After Administration of Epoetin Alpha Associated With an Oral Medical Supplementation Versus Intravenous Before Surgery of Craniosynostosis at the Child (IRON KID)

  • STATUS
    Recruiting
  • End date
    Jun 30, 2024
  • participants needed
    100
  • sponsor
    University Hospital, Montpellier
Updated on 26 February 2022

Summary

Oral iron is commonly used in conjunction with EPO preoperatively for hemorrhagic surgeries in children and especially in the surgery of craniosynostosis. The bioavailability of oral iron is low and compliance with treatment is inconsistent. The aim of this study is to evaluate whether the use of ferric carboxymaltose by injection, which has a much better bioavailability, would make it possible to increase the preoperative hemoglobin level more effectively and thus reduce the risk of perioperative blood transfusion .

Description

Prospective study, randomized in two parallel groups (martial treatment versus venous injection) and stratified by center (Montpellier, Nice, Angers).

The number of subjects required is 100 patients, or 50 per group.

Details
Condition Craniosynostosis
Treatment Ferrous fumarate, Ferrous fumarate or ferrostrane
Clinical Study IdentifierNCT03231085
SponsorUniversity Hospital, Montpellier
Last Modified on26 February 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Craniosynostosis Surgery
Age: between 4 and 24 months inclusive
Weight: less than 12kg
Hemoglobin: 10 g / dl ≤ Hb 14 ≤ g / dl
Affiliated patients or beneficiaries of a Social Security scheme
Signature of the consent of the patient's parents

Exclusion Criteria

Generalized infection
Time for consultation of anesthesia with respect to the date of surgery greater than 5 weeks or less than 22 days
Initial biological assessment dating more than 3 months before the consultation of anesthesia
Parents do not understand French
BMI greater than 20 kg.m-2
Contraindications to EPO
Contraindications to ferric carboxymaltose and to ferrous fumarate
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