EUCTR2010-024115-14-DE进行中（未招募）不适用
Preoperative Intravenous Ferric Carboxymaltose (Ferinject) in Patients with Orthopaedic Surgery and High Risk of Blood Loss - PRIVIRO
niversity Hospital Muenster0 个研究点开始时间: 2011年3月23日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 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
- •- Patients undergoing orthopedic surgery with risk of high blood loss
- •- anemia (Hb >= 8 g/dL and < 13 g/dL (men) respectively < 12 g/dL (women)
- •- ferritin < 100 µg/L or 100-300 with TSat < 20%
- •- age >= 18 years
- •- sign the informed consent form
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 140
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 140
排除标准
- •- history of thromboembolic events for the last 5 years
- •- concurrent medical condition(s) that would prevent compliance or participation or jeopardize the health of the patient
- •- Hypersensitivity to any component of the formulation
- •- transfusion within 1 month prior to study inclusion
- •- liver values 3 times higher than normal
- •- renal insufficiency (GFR < 30 mL/min/1,73 m²)
研究者
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