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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)

Primary Purpose

Craniosynostosis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ferrous fumarate or ferrostrane
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Craniosynostosis focused on measuring Craniosynostosis, hemoglobin, iron peros, iron intravenous

Eligibility Criteria

4 Months - 24 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of AngersRecruiting
  • University Hospital of MontpellierRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Ferrous fumarate or ferrostrane

Ferric carboxymaltose

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Variation from reference in hemoglobin rate at the day before surgery depending on the reference iron status
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
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
Number of patient stopping EPO injections at the end of 2nd injection
Variation from reference in iron status at the day before surgery
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
Comparision of adverse event du to experimental treatments (ferric carboxymaltose versus ferrous fumarate)
Compliance 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
Number of transfused patients among all patients
Number of packed red blood cells transfused in perioperative phase and during 3 days following
Volume of packed red blood cells transfused
Volume in mL/kg
Total perioperative blood loss
Expressed in red blood cell mass
Cost of oral ferrous fumarate treatment compared to ferric carboxymaltose treatment

Full Information

First Posted
June 27, 2017
Last Updated
December 22, 2021
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT03231085
Brief Title
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
Acronym
IRON KID
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
October 31, 2017 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Craniosynostosis
Keywords
Craniosynostosis, hemoglobin, iron peros, iron intravenous

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ferrous fumarate or ferrostrane
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Ferric carboxymaltose
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Ferrous fumarate or ferrostrane
Other Intervention Name(s)
Intravenous ferric carboxymaltose.
Intervention Description
Young children operated with craniosynostosis and treated with EPO and ferrous fumarate or ferostrane per os or intravenous ferric carboxymaltose.
Primary Outcome Measure Information:
Title
Variation from reference in hemoglobin rate at the day before surgery
Description
Variation of hemoglobin rate between reference value (collected right before the implementation of treatment) and preoperative hemoglobin rate (collected one 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)
Secondary Outcome Measure Information:
Title
Variation from reference in hemoglobin rate at the day before surgery depending on the reference iron status
Description
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
Time Frame
Reference day (right before treatment) and one day before surgery (from 22 days to 5 weeks maximum)
Title
Variation from reference in hemoglobin rate at the day before surgery depending on the inflammatory state of patient evaluated by CRP rate before treatment
Description
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
Time Frame
Reference day (right before treatment) and one day before surgery (from 22 days to 5 weeks maximum)
Title
Frequency of EPO treatment discontinuation at the end of 2nd injection
Description
Number of patient stopping EPO injections at the end of 2nd injection
Time Frame
15 days before surgery
Title
Variation from reference in iron status at the day before surgery
Description
Changes in iron status between reference day (right before the implementation of treatment) and preoperative iron status (one day before surgery)
Time Frame
Reference day (right before treatment) and one day before surgery (from 22 days to 5 weeks maximum)
Title
Occurrence of adverse events due to experimental treatments
Description
Comparision of adverse event du to experimental treatments (ferric carboxymaltose versus ferrous fumarate)
Time Frame
from treatment administration to end of patient follow-up
Title
Compliance of oral iron treatment
Description
Evaluated by visual analogic scale (0 the minimum to 10 the maximum)
Time Frame
At the end of oral iron treatment
Title
Rate of blood transfusion in perioperative phase and during 3 days following surgery
Description
Number of transfused patients among all patients
Time Frame
Perioperative phase and during 3 days following surgery
Title
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
Title
Volume of packed red blood cells transfused
Description
Volume in mL/kg
Time Frame
Perioperative phase and during 3 days following surgery
Title
Total perioperative blood loss
Description
Expressed in red blood cell mass
Time Frame
Perioperative phase and during 3 days following surgery
Title
Cost of oral ferrous fumarate treatment compared to ferric carboxymaltose treatment
Time Frame
At the end of patient folllow-up (6 months after surgery)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Philippe PIRAT, MD
Phone
0467338256
Email
p-pirat@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe PIRAT, MD
Organizational Affiliation
Department d'Anesthésie reanimation Lapeyronie
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Angers
City
Angers
ZIP/Postal Code
49100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sigismond LASOCKI, PU-PH
Email
silasocki@chu-angers.fr
First Name & Middle Initial & Last Name & Degree
Laurent COLBUS, MD
Email
lacolbus@chu-angers.fr
Facility Name
University Hospital of Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Bringuier, PharmaD
Phone
0467338256
Email
s-bringuierbranchereau@chu-montpellier.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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