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)

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 Overview

• Status: Recruiting
• Conditions: Craniosynostosis
• Intervention / Treatment: Drug: Ferrous fumarate or ferrostrane

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: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Philippe PIRAT, MD; Phone Number: 0467338256; Email: p-pirat@chu-montpellier.fr

Study Locations

• France
  • Angers, France, 49100
    • Recruiting
    • University Hospital of Angers
    • Contact: Sigismond LASOCKI, PU-PH; Email: silasocki@chu-angers.fr
    • Contact: Laurent COLBUS, MD; Email: lacolbus@chu-angers.fr
  • Montpellier, France, 34295
    • Recruiting
    • University Hospital of Montpellier
    • Contact: Sophie Bringuier, PharmaD; Phone Number: 0467338256; Email: s-bringuierbranchereau@chu-montpellier.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 months to 2 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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 Names: Intravenous ferric carboxymaltose.
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.	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 Names: Intravenous ferric carboxymaltose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Hemoglobin rate change from reference day (right before treatment) to one day before surgery (from 22 days to 5 weeks maximum)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Reference day (right before treatment) and one day before surgery (from 22 days to 5 weeks maximum)
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	Reference day (right before treatment) and one day before surgery (from 22 days to 5 weeks maximum)
Frequency of EPO treatment discontinuation at the end of 2nd injection	Number of patient stopping EPO injections at the end of 2nd injection	15 days before surgery
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)	Reference day (right before treatment) and one day before surgery (from 22 days to 5 weeks maximum)
Occurrence of adverse events due to experimental treatments	Comparision of adverse event du to experimental treatments (ferric carboxymaltose versus ferrous fumarate)	from treatment administration to end of patient follow-up
Compliance of oral iron treatment	Evaluated by visual analogic scale (0 the minimum to 10 the maximum)	At the end of oral iron treatment
Rate of blood transfusion in perioperative phase and during 3 days following surgery	Number of transfused patients among all patients	Perioperative phase and during 3 days following surgery
Number of packed red blood cells transfused in perioperative phase and during 3 days following		Perioperative phase and during 3 days following surgery
Volume of packed red blood cells transfused	Volume in mL/kg	Perioperative phase and during 3 days following surgery
Total perioperative blood loss	Expressed in red blood cell mass	Perioperative phase and during 3 days following surgery
Cost of oral ferrous fumarate treatment compared to ferric carboxymaltose treatment		At the end of patient folllow-up (6 months after surgery)

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Philippe PIRAT, MD, Department d'Anesthésie reanimation Lapeyronie

Study record dates

Study Major Dates

• Study Start (Actual): October 31, 2017
• Primary Completion (Anticipated): October 1, 2023
• Study Completion (Anticipated): June 1, 2024

Study Registration Dates

• First Submitted: June 27, 2017
• First Submitted That Met QC Criteria: July 24, 2017
• First Posted (Actual): July 27, 2017

Study Record Updates

• Last Update Posted (Actual): December 23, 2021
• Last Update Submitted That Met QC Criteria: December 22, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: hemoglobin; Craniosynostosis; iron peros; iron intravenous
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Bone Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Bone Diseases, Developmental; Dysostoses; Synostosis; Craniosynostoses; Physiological Effects of Drugs; Trace Elements; Micronutrients; Ferrous fumarate
• Other Study ID Numbers: 9769 (Fred Hutch/University of Washington Cancer Consortium); 2016-005065-31 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No