EUCTR2016-005065-31-FR进行中（未招募）1 期
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 个研究点开始时间: 2017年5月5日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •-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
排除标准
- •-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
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