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NCT Number: NCT03231085

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

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 .

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Key information

Conditions

Craniosynostosis Bone Diseases Bone Diseases, Developmental Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities Craniosynostoses Dysostoses Musculoskeletal Abnormalities Musculoskeletal Diseases Synostosis

Age range

4 month–24 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Angers, Angers, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Ferrous fumarate or ferrostrane

Drug

Young children operated with craniosynostosis and treated with EPO and ferrous fumarate or ferostrane per os or intravenous ferric carboxymaltose.

Other names: Intravenous ferric carboxymaltose.

Primary outcomes

  1. Variation from reference in hemoglobin rate at the day before surgery

    Time frame: Hemoglobin rate change from reference day (right before treatment) to one day before surgery (from 22 days to 5 weeks maximum)

    Variation of hemoglobin rate between reference value (collected right before the implementation of treatment) and preoperative hemoglobin rate (collected one day before surgery)

Secondary outcomes

  1. Variation from reference in hemoglobin rate at the day before surgery depending on the reference iron status

    Time frame: Reference day (right before treatment) and one day before surgery (from 22 days to 5 weeks maximum)

    Variation of hemoglobin rate between reference value (collected right before the implementation of treatment) and preoperative hemoglobin rate (collected one day before surgery) depending on the reference iron status

  2. Variation from reference in hemoglobin rate at the day before surgery depending on the inflammatory state of patient evaluated by CRP rate before treatment

    Time frame: Reference day (right before treatment) and one day before surgery (from 22 days to 5 weeks maximum)

    Variation of hemoglobin rate between reference value (collected right before the implementation of treatment) and preoperative hemoglobin rate (collected one day before surgery) depending on the CRP rate before treatment

  3. Frequency of EPO treatment discontinuation at the end of 2nd injection

    Time frame: 15 days before surgery

    Number of patient stopping EPO injections at the end of 2nd injection

  4. Variation from reference in iron status at the day before surgery

    Time frame: Reference day (right before treatment) and one day before surgery (from 22 days to 5 weeks maximum)

    Changes in iron status between reference day (right before the implementation of treatment) and preoperative iron status (one day before surgery)

  5. Occurrence of adverse events due to experimental treatments

    Time frame: from treatment administration to end of patient follow-up

    Comparision of adverse event du to experimental treatments (ferric carboxymaltose versus ferrous fumarate)

  6. Compliance of oral iron treatment

    Time frame: At the end of oral iron treatment

    Evaluated by visual analogic scale (0 the minimum to 10 the maximum)

  7. Rate of blood transfusion in perioperative phase and during 3 days following surgery

    Time frame: Perioperative phase and during 3 days following surgery

    Number of transfused patients among all patients

  8. Number of packed red blood cells transfused in perioperative phase and during 3 days following

    Time frame: Perioperative phase and during 3 days following surgery

  9. Volume of packed red blood cells transfused

    Time frame: Perioperative phase and during 3 days following surgery

    Volume in mL/kg

  10. Total perioperative blood loss

    Time frame: Perioperative phase and during 3 days following surgery

    Expressed in red blood cell mass

  11. Cost of oral ferrous fumarate treatment compared to ferric carboxymaltose treatment

    Time frame: At the end of patient folllow-up (6 months after surgery)

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: IRON KID

Important dates

Study start
2017
Primary completion
2024
Study completion
2024
First posted
Jul 27, 2017
Registry last updated
Dec 30, 2024

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

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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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