EUCTR2009-015013-46-GB
进行中（未招募）
1 期
The ATACAS Trial: Aspirin and Tranexamic Acid for Coronary Artery Surgery Trial - Aspirin and tranexamic acid for coronary artery surgery trial
概览
- 阶段
- 1 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- Alfred Health
- 入组人数
- 4600
- 状态
- 进行中（未招募）
- 最后更新
- 7年前
概览
简要总结
暂无简介。
研究者
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 \= or \> 70 years • 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 • Renal impairment (se. creatinine \>150 micromol/l or creatinine clearance \<45 ml/min) • Obesity (body mass index \>25 kg/m2\) • Pulmonary hypertension (mPAP \>25 mmHg) • Peripheral vascular disease.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 0
- •F.1\.3 Elderly (\>\=65 years) yes
- •F.1\.3\.1 Number of subjects for this age range 0
排除标准
- •1\. Poor (English) language comprehension 2\. Clinician preference for antifibrinolytic therapy 3\. Urgent surgery for unstable coronary syndromes 4\. Active peptic ulceration 5\. Allergy or contraindication to aspirin or tranexamic acid 6\. Aspirin therapy within 4 days of surgery (81\) 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 micromol/l, or estimated creatinine clearance \<25 ml/min) 10\. Recent haematuria 11\. Thromboembolic disease: history of postoperative or spontaneous pulmonary embolism, spontaneous arterial thrombosis or familial hypercoaguability (eg. Lupus anticoagulant, protein C deficiency) 12\. Pregnancy.
结局指标
主要结局
未指定
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