Craniosynostosis Clinical Trial
— IRON KIDOfficial 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
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 .
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 4 Months to 24 Months |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | University Hospital of Angers | Angers | |
France | University Hospital of Montpellier | Montpellier |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Montpellier |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) | |
Secondary | 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) | |
Secondary | 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 | |
Secondary | 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) | |
Secondary | 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 | |
Secondary | Compliance of oral iron treatment | Evaluated by visual analogic scale (0 the minimum to 10 the maximum) | At the end of oral iron treatment | |
Secondary | 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 | |
Secondary | Number of packed red blood cells transfused in perioperative phase and during 3 days following | Perioperative phase and during 3 days following surgery | ||
Secondary | Volume of packed red blood cells transfused | Volume in mL/kg | Perioperative phase and during 3 days following surgery | |
Secondary | Total perioperative blood loss | Expressed in red blood cell mass | Perioperative phase and during 3 days following surgery | |
Secondary | Cost of oral ferrous fumarate treatment compared to ferric carboxymaltose treatment | At the end of patient folllow-up (6 months after surgery) |
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