Pilot Study for Investigation of the Feasibility and for Optimization of Oral Iron Substitution in the Course of Patient Blood Management for Orthopedic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- increase of hemoglobin level
研究概览
简要总结
The aim of this pilot study is to investigate an 4 weeks period of oral iron substitution in the course of Patient Blood Management in preparation for orthopedic surgery.
详细描述
Patient blood management (PBM) is a clinical multidisciplinary, patient orientated concept for treatment of anaemia, reduction of intraoperative blood loss and increasing anaemic tolerance.
In the Kepler University Hospital (former General Hospital Linz) PBM was introduced in 2006. Since then patients for elective orthopedic surgery (knee an hip replacement) are screened for iron deficiency anaemia and if needed treated with the more effective intravenous iron.
Oral iron medications are not as efficient (low bioavailability, more side effects) as the intravenous iron infusion. Although there is risk of anaphylactoid reactions.
In this study the new oral iron supplement OLEOvital Eisen forte (available in Austria) ist tested on its effectivity for treatment of iron deficiency in the course of PBM.
It has a much more higher bioavailability without the typically side effects of the routinely used oral iron medications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age over 55 years
- •indication for patient blood management for elective orthopedic surgery
- •listed for a orthopedic surgery (e.g. hip or knee replacement) 5-7 weeks after begin of patient blood management
- •Haemoglobin male < 12-13g/dl, female <11-12g/dl
- •written informed consent after written and verbal information
排除标准
- •indication for treatment with erythropoietin
- •pregnancy
- •nursing period
- •diarrhea or tendency to diarrhea
- •fructose intolerance
- •pre - menopause
- •permanent or expected blood loss
- •participation in other study
- •expected compliance problems
- •legal incapacity
结局指标
主要结局
increase of hemoglobin level
时间窗: 4 weeks
次要结局
未报告次要终点
研究者
Nina Pauker, MD
Dr. med. univ.
Kepler University Hospital