Status:
COMPLETED
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
Lead Sponsor:
University Hospital, Montpellier
Conditions:
Craniosynostosis
Eligibility:
All Genders
4-24 years
Phase:
NA
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 c...
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,...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 31 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 3 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03231085
Start Date
October 31 2017
End Date
October 3 2024
Last Update
December 30 2024
Active Locations (2)
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1
University Hospital of Angers
Angers, France, 49100
2
University Hospital of Montpellier
Montpellier, France, 34295