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
NCT ID: NCT03231085
Last Updated: 2024-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2017-10-31
2024-10-03
Brief Summary
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Detailed Description
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The number of subjects required is 100 patients, or 50 per group.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Ferrous fumarate or ferrostrane
Young children operated with craniosynostosis and treated with EPO and ferrous fumarate or ferostrane per os or intravenous ferric carboxymaltose.
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.
Ferrous fumarate or ferrostrane
Young children operated with craniosynostosis and treated with EPO and ferrous fumarate or ferostrane per os or intravenous ferric carboxymaltose.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
4 Months
24 Months
ALL
No
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Philippe PIRAT, MD
Role: PRINCIPAL_INVESTIGATOR
Department d'Anesthésie reanimation Lapeyronie
Locations
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University Hospital of Angers
Angers, , France
University Hospital of Montpellier
Montpellier, , France
Countries
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Other Identifiers
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2016-005065-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
9769
Identifier Type: -
Identifier Source: org_study_id