ISRCTN47685900已完成不适用
A randomised, double-blind, placebo-controlled study of Glypromate® in patients undergoing cardiopulmonary bypass surgery: Studying Neurons Using Glypromate® - second study
euren Pharmaceuticals Limited (New Zealand)0 个研究点目标入组 350 人开始时间: 2007年7月5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
- 350
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
- All
入选标准
- •1. Scheduled for non-emergency CABG surgery and/or valve replacement/repair, with CPB
- •2. Willing to provide written informed consent
- •3. Able and agreeable to undergo all cognitive and Activities of Daily Living (ADL) testing (i.e. understands English, able to read, write, have sufficient motor dexterity and be available for follow-up visit at 4 - 6 weeks and 12 - 14 weeks post surgery)
- •4. Greater than or equal to 50 years old
排除标准
- •1. Pre-operative mechanical assist device or intra-aortic balloon pump inserted for shock or low output syndrome
- •2. Women of child-bearing potential or breastfeeding women
- •3. History of or any current condition that in the Investigator's opinion would interfere with study participation or evaluation of results
- •4. Congenital heart disease with a risk of polycythaemia, circulatory problems, or need for a shunt
- •5. Renal insufficiency (serum creatinine greater than 180 umol/L [greater than 2 mg/dL])
- •6. Past or present bleeding disorder
- •7. History of organic brain syndrome
- •8. Currently receiving treatment for alcohol or drug abuse
- •9. Currently participating in another investigational drug or device study
- •10. Prior enrolment in this study
研究者
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