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临床试验/NL-OMON40015
NL-OMON40015
已完成
不适用

The ATACAS Trial: Aspirin and Tranexamic Acid for Coronary Artery Surgery Trial. A prospective, randomised, double blind, factorial trial testing whether aspirin, tranexamic acid, or both, can reduce mortality and/or major morbidity after elective coronary artery surgery. - ATACAS Trial

Alfred Hospital0 个研究点目标入组 29 人待定

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
CABG
发起方
Alfred Hospital
入组人数
29
状态
已完成
最后更新
2年前

概览

简要总结

Trial is onging in other countries

注册库
who.int
开始日期
待定
结束日期
2016年10月15日
最后更新
2年前
研究类型
Interventional

研究者

发起方
Alfred Hospital

入排标准

入选标准

  • 1\. Males and females, age 18 years and over
  • 2\. Written, informed consent
  • 3\. Elective coronary artery surgery (on\-pump or off\-pump)
  • 4\. Patient is at increased risk of major complications, defined by any of:
  • \* Age 70 years and over
  • \* Left ventricular impairment (fractional area change \<20%, ejection fraction \<40%, or at least moderate impairment on ventriculography)
  • \* Concomitant valvular or aortic surgery
  • \* Aneurysmectomy
  • \* Repeat cardiac surgery (\*re\-do\*)
  • \* Chronic obstructive pulmonary disease

排除标准

  • 1\. Poor (Dutch) language comprehension
  • 2\. Clinician preference for antifibrinolytic therapy
  • 3\. Urgent surgery for unstable coronary syndromes where for clinical reasons antiplatelet medication cannot be discontinued
  • 4\. Active peptic ulceration
  • 5\. Allergy or contraindication to aspirin or tranexamic acid
  • 6\. Aspirin therapy within 4 days of surgery
  • 7\. Warfarin or clopidogrel therapy within 7 days of surgery, or GIIb/IIIa antagonists within 24 h of surgery
  • 8\. Thrombocytopaenia or any other known history of bleeding disorder
  • 9\. Severe renal impairment (serum creatinine \>250 \*mol/l, or estimated creatinine clearance \<25 ml/min)
  • 10\. Recent haematuria

结局指标

主要结局

未指定

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