drugset / Trial / NCT03231085

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 100 enrolled University Hospital, Montpellier
RandomizedParallel-groupSingle-blindTreatment

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 .

Timeline

Start
2017-10-31
Primary completion
2024-04-11
Completion
2024-10-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Ferric carboxymaltose Other / unclassified 15 mg/kg Intravenous
Subject Ferrous Sulfate Diagnostic / imaging agent 200 mg Oral
Subject Ferrous Sulfate Diagnostic / imaging agent 300 mg Oral
Subject Ferrous Sulfate Diagnostic / imaging agent 400 mg Oral
Subject ferrostrane Unknown 2 unknown Oral
Subject ferrostrane Unknown 3 unknown Oral

Indications