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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Craniosynostosis

Intervention / Treatment
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* Drug: Ferrous fumarate or ferrostrane


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Months
Maximum Age: 24 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ferrous fumarate or ferrostrane<br>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. | Drug: Ferrous fumarate or ferrostrane<br>* Young children operated with craniosynostosis and treated with EPO and ferrous fumarate or ferostrane per os or intravenous ferric carboxymaltose.<br>* Other names: Intravenous ferric carboxymaltose.;|
| Experimental: Ferric carboxymaltose<br>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. | Drug: Ferrous fumarate or ferrostrane<br>* Young children operated with craniosynostosis and treated with EPO and ferrous fumarate or ferostrane per os or intravenous ferric carboxymaltose.<br>* Other names: Intravenous ferric carboxymaltose.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation from reference in hemoglobin rate at the day before surgery | Variation of hemoglobin rate between reference value (collected right before the implementation of treatment) and preoperative hemoglobin rate (collected one day before surgery) | Hemoglobin rate change from reference day (right before treatment) to one day before surgery (from 22 days to 5 weeks maximum) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation from reference in hemoglobin rate at the day before surgery depending on the reference iron status | Variation of hemoglobin rate between reference value (collected right before the implementation of treatment) and preoperative hemoglobin rate (collected one day before surgery) depending on the reference iron status | Reference day (right before treatment) and one day before surgery (from 22 days to 5 weeks maximum) | 
| Variation from reference in hemoglobin rate at the day before surgery depending on the inflammatory state of patient evaluated by CRP rate before treatment | Variation of hemoglobin rate between reference value (collected right before the implementation of treatment) and preoperative hemoglobin rate (collected one day before surgery) depending on the CRP rate before treatment | Reference day (right before treatment) and one day before surgery (from 22 days to 5 weeks maximum) | 
| Frequency of EPO treatment discontinuation at the end of 2nd injection | Number of patient stopping EPO injections at the end of 2nd injection | 15 days before surgery | 
| Variation from reference in iron status at the day before surgery | Changes in iron status between reference day (right before the implementation of treatment) and preoperative iron status (one day before surgery) | Reference day (right before treatment) and one day before surgery (from 22 days to 5 weeks maximum) | 
| Occurrence of adverse events due to experimental treatments | Comparision of adverse event du to experimental treatments (ferric carboxymaltose versus ferrous fumarate) | from treatment administration to end of patient follow-up | 
| Compliance of oral iron treatment | Evaluated by visual analogic scale (0 the minimum to 10 the maximum) | At the end of oral iron treatment | 
| Rate of blood transfusion in perioperative phase and during 3 days following surgery | Number of transfused patients among all patients | Perioperative phase and during 3 days following surgery | 
| Number of packed red blood cells transfused in perioperative phase and during 3 days following |  | Perioperative phase and during 3 days following surgery | 
| Volume of packed red blood cells transfused | Volume in mL/kg | Perioperative phase and during 3 days following surgery | 
| Total perioperative blood loss | Expressed in red blood cell mass | Perioperative phase and during 3 days following surgery | 
| Cost of oral ferrous fumarate treatment compared to ferric carboxymaltose treatment |  | At the end of patient folllow-up (6 months after surgery) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Craniosynostosis, hemoglobin, iron peros, iron intravenous