Assessment of the administration of epoetin with intraveinous martial supplementation before craniosynostosis in childre

Phase 1

• Conditions: Craniosynostosis; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2016-005065-31-FR
• Lead Sponsor: niversity hospital of Montpellier

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-05
• Last Update Posted: 10 July 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified