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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)

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ClinicalTrials.gov Identifier: NCT03231085
Recruitment Status : Recruiting
First Posted : July 27, 2017
Last Update Posted : March 31, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Tracking Information
First Submitted Date  ICMJE June 27, 2017
First Posted Date  ICMJE July 27, 2017
Last Update Posted Date March 31, 2020
Actual Study Start Date  ICMJE October 31, 2017
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2017)
Preoperative hemoglobin [ Time Frame: day before surgery ]
Preoperative hemoglobin
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2017)
The number of patients transfused [ Time Frame: within 3 days post operative ]
The number of patients transfused and the quantity in ml / kg of transfused
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief 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 .
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Craniosynostosis
Intervention  ICMJE 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.
Other Name: Intravenous ferric carboxymaltose.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Ferrous fumarate or ferrostrane
  • Experimental: Ferinject
    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.
    Intervention: Drug: Ferrous fumarate or ferrostrane
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 24, 2019)
100
Original Estimated Enrollment  ICMJE
 (submitted: July 24, 2017)
50
Estimated Study Completion Date  ICMJE June 2024
Estimated Primary Completion Date October 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Months to 24 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Philippe PIRAT, MD 0467338256 p-pirat@chu-montpellier.fr
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03231085
Other Study ID Numbers  ICMJE 9769
2016-005065-31 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Montpellier
Study Sponsor  ICMJE University Hospital, Montpellier
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philippe PIRAT, MD Department d'Anesthésie reanimation Lapeyronie
PRS Account University Hospital, Montpellier
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP