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

Overview

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 .

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Care Provider)
  • Study Primary Completion Date: October 2023

Detailed 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.

Interventions

  • Drug: Ferrous fumarate or ferrostrane
    • Young children operated with craniosynostosis and treated with EPO and ferrous fumarate or ferostrane per os or intravenous ferric carboxymaltose.

Arms, Groups and Cohorts

  • Active Comparator: Ferrous fumarate or ferrostrane
    • The oral treatment should begin 21 days before surgery. Recommended Dosage ferrous fumarate according to the SPC in force: 5 to 8 kg: 2 cd rases / d or 200mg of ferrous fumarate 8 to 10 kg: 3 cd rases / d or 300mg of ferrous fumarate 10 to 12kg: 4 cd rases / d or 400mg of ferrous fumarate Ferrostrane ® (syrup) Laboratory TEOFARMA SRL Either 34mg of iron per teaspoon Recommended dosage according to the SPC in force: Infant 5 to 8 kg (about 1 to 6 months): 2 teaspoons a day, Infant from 8 to 12 kg (about 6 to 30 months): 3 teaspoons a day.
  • Experimental: Ferric carboxymaltose
    • The single intravenous treatment the day of the inclusion. Dosage according to: 15mg / kg iron (to dilute in 3 ml / kg of Nacl 0.9% (SSI), to pass in 15 minutes.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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
  • 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
  • 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
  • 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)
  • 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)
  • 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)
  • 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
  • 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
  • Volume of packed red blood cells transfused
    • Time Frame: Perioperative phase and during 3 days following surgery
    • Volume in mL/kg
  • Total perioperative blood loss
    • Time Frame: Perioperative phase and during 3 days following surgery
    • Expressed in red blood cell mass
  • Cost of oral ferrous fumarate treatment compared to ferric carboxymaltose treatment
    • Time Frame: At the end of patient folllow-up (6 months after surgery)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 4 Months

Maximum Age: 24 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University Hospital, Montpellier
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Philippe PIRAT, MD, Principal Investigator, Department d’Anesthésie reanimation Lapeyronie
  • Overall Contact(s)
    • Philippe PIRAT, MD, 0467338256, p-pirat@chu-montpellier.fr

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