ISRCTN84413719已完成不适用
Randomised double-blind phase IV clinical trial on 24 hours duration of various groups of tranexamic acid treatment on the effectiveness in the prevention of systemic inflammatory response syndrome and post-operative bleeding in elective cardiopulmonary bypass patients
Hospital Universitario de Canarias (Spain)0 个研究点目标入组 160 人开始时间: 2009年7月15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
- 160
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. Equal or older than 18 years old, either sex
- •2. Elective cardiopulmonary bypass surgery
- •3. Informed consent approval
排除标准
- •1. Younger than 18 years old
- •2. Tranexamic acid hypersensibility
- •3. Gross haematuria
- •4. Emergency interventions
- •5. Off-pump cardiac surgery
- •6. Patients with a history of:
- •6.1. Chronic coagulopathy (prothrombin time [PT] of less than 50% or international normalised ratio of greater than 2 and platelets of less than 50,000/mm^3 or aggregation dysfunction)
- •6.2. Renal failure (creatinine of greater than 2 mg/dl)
- •6.3. Chronic hepatopathy (Child B or higher degree)
- •6.4. Use of immunosuppressant drugs
- •6.5. Endocarditis, sepsis in the first 24 hours after intervention, or
- •6.6. Unwillingness to enrol
- •6.7. Use of anti-inflammatory agents such as corticosteroids or non-steroidal anti-inflammatory agents, on the previous 5 days before intervention
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