EUCTR2018-000017-20-DE进行中（未招募）1 期
Antiplatelet effect of acetylsalicylic acid in patients after cardiac surgery: Impact of dipyrone (metamizole) - Aspirin-Metamizole Drug-Drug Interaction
niversitäts-Herzzentrum Freiburg • Bad Krozingen0 个研究点目标入组 150 人开始时间: 2018年5月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •-Clinical indication for surgical replacement of the stenotic aortic valve by a bioprosthesis without concomitant CABG or surgical mitral valve repair
- •-Age > 50years
- •-Written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 135
排除标准
- •-Re-do heart surgery
- •-Indication for oral anticoagulation
- •-Known disorders of coagulation
- •-Chronic hepatic disease
- •-Chronic alcohol abuse
- •-Known malnutrition status
- •-Creatine clearance <30 ml7Min (CKD-EPI-formula)
- •-End-stage renal disease requring hemodialysis
- •-Known hematological disorders
- •-Peri-or postoperative transfusion of platelets
- •-Treatment with aspirin within 10 days prior to surgery
- •-Positive result in pregnancy in urine testing in female pre-menopausal patients
- •-Participation in any interventional study according to German Drug Law (AMG) or Medicinal Device Law (MPG) within 30 days before enrollment in this study
- •-Known hypersensitivity to dipyrone (metamizole) or paracetamol
研究者
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