Clinical 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
Official title: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Craniosynostosis
Keywords: Craniosynostosis
hemoglobin
iron peros
iron intravenous
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2017-07-27
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Variation from reference in hemoglobin rate at the day before surgery
timeFrame: Hemoglobin rate change from reference day (right before treatment) to one day before surgery (from 22 days to 5 weeks maximum)
Secondary outcomes:
measure: Variation from reference in hemoglobin rate at the day before surgery depending on the reference iron status
timeFrame: Reference day (right before treatment) and one day before surgery (from 22 days to 5 weeks maximum)
measure: Variation from reference in hemoglobin rate at the day before surgery depending on the inflammatory state of patient evaluated by CRP rate before treatment
timeFrame: Reference day (right before treatment) and one day before surgery (from 22 days to 5 weeks maximum)
measure: Frequency of EPO treatment discontinuation at the end of 2nd injection
timeFrame: 15 days before surgery
measure: Variation from reference in iron status at the day before surgery
timeFrame: Reference day (right before treatment) and one day before surgery (from 22 days to 5 weeks maximum)
measure: Occurrence of adverse events due to experimental treatments
timeFrame: from treatment administration to end of patient follow-up
measure: Compliance of oral iron treatment
timeFrame: At the end of oral iron treatment
measure: Rate of blood transfusion in perioperative phase and during 3 days following surgery
timeFrame: Perioperative phase and during 3 days following surgery
measure: Number of packed red blood cells transfused in perioperative phase and during 3 days following
timeFrame: Perioperative phase and during 3 days following surgery
measure: Volume of packed red blood cells transfused
timeFrame: Perioperative phase and during 3 days following surgery
measure: Total perioperative blood loss
timeFrame: Perioperative phase and during 3 days following surgery
measure: Cost of oral ferrous fumarate treatment compared to ferric carboxymaltose treatment
timeFrame: At the end of patient folllow-up (6 months after surgery)
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital of Angers
city: Montpellier
country: France
facility: University Hospital of Montpellier
Study officials:
affiliation: Department d'Anesthésie reanimation Lapeyronie
name: Philippe PIRAT, MD
role: PRINCIPAL_INVESTIGATOR
References: