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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 4 Months – 24 Months
• Healthy volunteers: Not accepted

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 .

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, or 50 per group.

Conditions

• Craniosynostosis

Interventions

Type	Name	Description
DRUG	Ferrous fumarate or ferrostrane	Young children operated with craniosynostosis and treated with EPO and ferrous fumarate or ferostrane per os or intravenous ferric carboxymaltose.

Timeline

• Start date: 2017-10-31
• Primary completion: 2024-04-11
• Completion: 2024-10-03
• First posted: 2017-07-27
• Last updated: 2024-12-30

Locations

2 sites across 1 country: France