跳至主要内容
临床试验/CTRI/2012/07/002767
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

发起方
ational Health and Medical Research Council

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