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 人开始时间: 待定最近更新: 2024年4月29日

适应症

试验速览

Trial is onging in other countries

•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
•* Renal impairment (se. creatinine >150 *mol/l or creatinine clearance <45 ml/min)
•* Obesity (body mass index >25 kg/m2)
•* Pulmonary hypertension (mPAP >25 mmHg)
•* Peripheral vascular disease.

•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
•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.

发起方

Alfred Hospital