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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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 .

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4 months
Maximum Age: 2
Healthy Volunteers: No
View:

• 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

Locations
Other Locations
France
University Hospital of Angers
Recruiting
Angers
University Hospital of Montpellier
Recruiting
Montpellier
Contact Information
Primary
Philippe PIRAT, MD
p-pirat@chu-montpellier.fr
0467338256
Time Frame
Start Date: October 31, 2017
Estimated Completion Date: June 2024
Participants
Target number of participants: 100
Treatments
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.
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.
Authors
Philippe PIRAT
Sponsors
Leads: University Hospital, Montpellier

This content was sourced from clinicaltrials.gov

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