EUCTR2016-005065-31-FR
Active, not recruiting
Phase 1
Comparison of preoperative hemoglobin after administration of epoetin alpha associated with oral martial supplementation vs intraveinous martial supplementation before craniosynostosis in children
niversity hospital of Montpellier0 sitesMay 5, 2017
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Craniosynostosis
- Sponsor
- niversity hospital of Montpellier
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
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
Outcomes
Primary Outcomes
Not specified
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