Craniosynostosis
Conditions
Interventions
Trade Name: FERINJECT
Pharmaceutical Form: Solution for injection
INN or Proposed INN: FERRIC CARBOXYMALTOSE
CAS Number: 9007-72-1
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: e
Sponsors
University hospital of Montpellier
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Craniosynostosis Surgery - Age: between 4 and 24 months - Weight: less than 12kg - Hemoglobin: 10 g / dl = Hb 14 = g / dl - Affiliated patients or beneficiaries of a health protection - Signature of the consent of the patient's parents Are the trial subjects under 18? yes Number of subjects for this age range: 50 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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: - Erythroblastopenia following treatment with epoetin alpha -Malignant and uncontrolled HTA - Hypersensitivity to Eprex® - Severe cardio-vascular disease - Severe thromboembolic risk -Evolutionary neoplastic pathology - Contraindications to Ferinject® and Fumafer®: - Known hypersensitivity to Ferinject® or Fumafer® or to any of its excipients - Known severe hypersensitivity to any other parenteral iron Fertilization> 200 µg / l or CST> 45% o All situations of martial overload (especially normo or hypersidemic anemia such as thalassemia, refractory anemia, anemia due to medullary insufficiency) or iron use disorders (hemochromatosis, haemosiderosis) . Known hepatic dysfunction - Chronic renal insufficiency - Late cutaneous porphyria
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of two strategies of martial supplementation, oral or intravenous associated with EPO on preoperative hemoglobin in children before Craniosynostosis;Secondary Objective: To compare the changes in Hemoglobin after EPO administration as a function of the reference martial balance (at inclusion), in both groups. - To Compare between the 2 groups: • the rates of patients who did not receive the 3rd injection of EPO because their hemoglobin rate was greater than or equal to 15 g / dl after the 2nd injection. • the evolution of the martial stock between the 2 groups • the occurrence of treatment-related adverse events • the compliance of martial treatment • blood savings calculated by the assessment of perioperative blood loss, • the number of patients transfused and the quantity in ml / kg of transfused blood • treatment costs;Primary end point(s): Variation of the Hb level between the reference value taken immediately before the introduction of the treatment and the preoperative Hemoglobin taken the day before surgery ;Timepoint(s) of evaluation of this end point: the day before surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1.Change in Hemoglobin rate between the reference value taken immediately before the introduction of the treatment and the preoperative Hb taken the day before the intervention, according to the reference martial balance. 2.Change in Hb between the reference value taken immediately before the introduction of the treatment and the preoperative Hb taken at D-1, the day before the intervention, according to the patient's inflammatory state Evaluated by the PRC level before treatment. 3.Frequency of stopping EPO treatment at the end of the 2nd injection 4. Evolution of the martial stock: before treatment and the day before the intervention 5. Occurrence of adverse events 6. Compliance of martial treatment per os evaluated by an observational scale and an analogic visual scale. 7. Use of intraoperative blood transfusion (and SSPI) and within 3 postoperative days. 8. Number of intraoperative transfused red blood cells (and SSPI) and within 3 postoperative days. 9. Volume of transfused globulin concentrate in ml / kg 10. Blood loss at day 3 11. Cost of treatment with Fumafer compared to treatment with Ferinject;Timepoint(s) of evaluation of this end point: 1. The day before the surgery 2. The day before the surgery 3. until the surgery 4.The day before the surgery 5.until 3 days after the surgery 6.The day before the surgery 7.until 3 days after the surgery 8.Until 3 days after the surgery 9.Until 3 days after the surgery 10.Until 3 days after the surgery 11. At the end of the study | — |
Countries
France
Contacts
Public ContactChauveton Claire
University Hospital of Montpellier
Outcome results
None listed