ISRCTN99578441已完成不适用
eukocyte Depletion of Autologous Whole Blood: impact on perioperative infection rate and length of hospital stay for hip arthroplasty patients
niversity of Heidelberg (Germany)0 个研究点目标入组 1,089 人开始时间: 2003年9月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,089
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •Hip arthroplasty patients
- •Added as of 16/12/2008:
- •1. American Society of Anaesthesiologists (ASA) grade I - III
- •2. Aged 18 - 85 years
- •3. Body weight 50 - 125 kg
- •4. If female, with either a history of an accepted method of anticonception for at least 3 months prior and 1 month following the termination of the study or climacteric or with a negative beta-human chorionic gonadotropin (B-HCG) test in urine or serum
- •5. Pre-operative blood donation of at least 2 units (450 ml whole blood)
- •6. Pre-operative haemoglobin level greater than 10 mg/dl
- •7. Able and willing to sign informed consent
排除标准
- •Added 16/12/2008:
- •1. Subjects with a contraindication for pre-operative blood donation (PAD)
- •2. Systemic infection
- •3. Acute bacterial or viral diseases
- •4. Anaemia (haemogoblin [Hb] greater than 11 g/dL)
- •5. Myocardial infarction within the past 6 months
- •6. Unstable angina pectoris
- •7. Vascular stenosis (i.e. of the coronary or internal carotid arteries)
- •8. Haemodynamic relevant valvular stenosis
- •9. Heart failure greater than New York Heart Association (NYHA) II
- •10. History of strokes or transient ischaemic attack (TIA)
- •11. Steroid therapy
- •12. Immune deficiency
- •13. Haematological or endocrinological disease
- •14. Coagulopathy
- •15. History of organ transplantation
- •16. Simultaneous participation in a second study
- •17. Pregnancy
- •18. Membership at Jehovah's Witnesses
- •19. Intended use of a cell saver
研究者
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