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 (IRON KID)

University Hospital Center (CHU)

Status: Completed

Conditions: Craniosynostosis

Treatments: Drug: Ferrous fumarate or ferrostrane

Study type: Interventional

Funder types: Other

Identifiers

NCT03231085

9769

2016-005065-31 (EudraCT Number)

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 4 to 24 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

100 participants in 2 patient groups

Ferrous fumarate or ferrostrane

Active Comparator group

Description:

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.

Treatment:

Drug: Ferrous fumarate or ferrostrane

Ferric carboxymaltose

Experimental group

Description:

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.

Treatment:

Drug: Ferrous fumarate or ferrostrane