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

9769

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 .

2017-10-31

2024-09-01

2024-12-01

Recruiting

100

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

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}

2024-05-29