EUCTR2018-003184-65-AT进行中（未招募）1 期
POREIIL - Postoperative replacement of intraoperative iron losses - POREII
Vifor Pharma0 个研究点目标入组 360 人开始时间: 2020年1月30日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 360
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 non-emergency
- •- cardiac surgery - intra-abdominal surgery • preoperative Hb (during the premedication visit):
- •-male: Hb>12.5g/dl
- •-female: Hb>11.5g/dl
- •postoperative Hb (immediately after surgical procedure in the recovery room):
- •-2 g/dl below preoperative Hb concentration
- •age = 18 years
- •Admission to intensive care unit or post-anesthesia care unit • Able to sign consent for the trial
- •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 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 180
排除标准
- •age < 18 years
- •emergency surgery
- •perioperative application of iron and/or erythropoietin • intraoperative transfusion of allogeneic erythrocytes
- •known hemochromatosis
- •known allergic reaction linked to iron medication
- •pregnancy
研究者
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