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

NCT03231085 | Completed DMC

• 2 other identifiers: 97692016-005065-31
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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 .

Conditions

Craniosynostosis

Keywords

Craniosynostosis; hemoglobin; iron peros; iron intravenous

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Variation from reference in hemoglobin rate at the 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

  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

  15 days before surgery

• Variation from reference in iron status at the 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

  from treatment administration to end of patient follow-up

Study Arms (2)

Ferrous fumarate or ferrostrane

ACTIVE COMPARATOR

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

Ferric carboxymaltose

EXPERIMENTAL

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

Interventions

Ferrous fumarate or ferrostrane DRUG

Young children operated with craniosynostosis and treated with EPO and ferrous fumarate or ferostrane per os or intravenous ferric carboxymaltose.

Also known as: Intravenous ferric carboxymaltose.

Ferric carboxymaltose; Ferrous fumarate or ferrostrane

Eligibility Criteria

• Age: 4 Months - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (2)

University Hospital of Angers

Angers, 49100, France

Location

University Hospital of Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Craniosynostoses

Interventions

ferrous fumarate; Fe(III)-EDTA

Condition Hierarchy (Ancestors)

Synostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Philippe PIRAT, MD

  Department d'Anesthésie reanimation Lapeyronie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2017
• First Posted: July 27, 2017
• Study Start: October 31, 2017
• Primary Completion: April 11, 2024
• Study Completion: October 3, 2024
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)