CTRI/2012/07/002767尚未招募4 期
Aspirin and tranexamic acid for coronary artery surgery trial. A collaborative project conducted by the Australian and New Zealand College of Anaesthetist Trials Group (ANZCA TG), and the NHMRC centre for clinical Research Excellence in Therapeutics - ATACAS
ational Health and Medical Research Council0 个研究点目标入组 4,600 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 4,600
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
入选标准
- •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
- •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 (â??re-doâ??)
- •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.
排除标准
- •1.Poor 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 ï?mol/l, or estimated creatinine clearance 25 ml/min)
- •10.Recent haematuria
- •11.Thromboembolic disease relating to: history of postoperative or spontaneous pulmonary embolism, spontaneous arterial thrombosis or familial hypercoaguability (eg. Lupus anticoagulant, protein C deficiency)
- •12.Pregnancy.
研究者
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