Comparison of preoperative hemoglobin after administration of epoetin alpha associated with oral martial supplementation vs intraveinous martial supplementation before craniosynostosis in children

Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2017
INTERVENTION: 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: equal Concentration number: 15‐ Trade Name: FUMAFER Pharmaceutical Form: Powder for oral solution CONDITION: Craniosynostosis Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Anesthesia and Analgesia [E03] PRIMARY OUTCOME: 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 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; 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 Timepoint(s) of evaluation of this end point: the day before surgery; SECONDARY OUTCOME: 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 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
Epistemonikos ID: bcf4c038fdafac877c0925f96f7d44c19a7ff599
First added on: Aug 23, 2024