ISRCTN86152982已完成不适用
Evaluation of Haemate HS for the treatment of severe intraoperative hemorrhage during aortic-valve replacement in patients with aortic-valve stenosis
Heinrich Heine University Duesseldorf (Germany)0 个研究点目标入组 40 人开始时间: 2008年2月8日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
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. Patients with isolated valvular aortic stenosis or combined aortic-valve defect with prevailing stenosis (mean transvalvular gradient >50 mmHg) with severe bleeding during aortic-valve replacement
- •2. Age >18 years.
- •3. Written informed consent.
- •4. All patients that fulfill at least one of the following criteria 15 minutes after the end of extracorporal circulation and application of protamine:
- •4.1. Excessive bleeding without surgical explanation according to the surgeons' impression (Classification of bleeding as normal, moderate or excessive by the surgeon. Classification as excessive bleeding leads to recruitment to the study).
- •4.2. Drainage volume >40 ml in 5 minutes following application of protamine and thorax closure.
排除标准
- •1. Participation in other interventional studies that potentially impair the interpretation of results
- •2. History suggestive for inherited or acquired bleeding disorder
- •3. Written informed consent not to be obtained
- •4. Active endocarditis
- •5. Concomitant coronary heart disease
- •6. Agents impairing platelet function at the time of surgery
- •7. Pregnancy
- •8. Known or suspected intolerance against Haemate HS
- •9. Previous thromboembolic complications
- •10. Known hepatitis B, hepatitis C or HIV infection
- •11. Known or suspected intolerance against standard medication (e.g., heparin)
- •12. Emergency surgery within the last 7 days
- •13. Previous chemotherapy
研究者
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