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

Craniosynostosis Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03231085
• Other study ID #: 9769
• Secondary ID: 2016-005065-31
• Status: Recruiting
• Phase: N/A
• Start date: October 31, 2017
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: University Hospital, Montpellier
• Contact: Philippe PIRAT, MD
• Phone: 0467338256
• Email: p-pirat[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Months to 24 Months

Eligibility

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

Related Conditions & MeSH terms

• Craniosynostoses
• Craniosynostosis

Intervention

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.

Locations

Country	Name	City	State
France	University Hospital of Angers	Angers
France	University Hospital of Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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
Secondary	Compliance of oral iron treatment	Evaluated by visual analogic scale (0 the minimum to 10 the maximum)	At the end of oral iron treatment
Secondary	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
Secondary	Number of packed red blood cells transfused in perioperative phase and during 3 days following		Perioperative phase and during 3 days following surgery
Secondary	Volume of packed red blood cells transfused	Volume in mL/kg	Perioperative phase and during 3 days following surgery
Secondary	Total perioperative blood loss	Expressed in red blood cell mass	Perioperative phase and during 3 days following surgery
Secondary	Cost of oral ferrous fumarate treatment compared to ferric carboxymaltose treatment		At the end of patient folllow-up (6 months after surgery)