Coronary Artery Bypass Grafting
Conditions
Interventions
Trade Name: Aspirin protect 100mg
Product Name: Aspirin
Product Code: 16854.01.01
Pharmaceutical Form: Coated tablet
Pharmaceutical form of the placebo: Coated tablet
Route of administration of the pl
Sponsors
Alfred Health
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 150 micromol/l or creatinine clearance 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
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: i. Should low-dose aspirin be continued up until the day of Coronary Artery Bypass Graft(CABG) surgery? ii. Should tranexamic acid be used for all at-risk CABG surgery?;Secondary Objective: Primary Endpoint; A composite endpoint including 30-day mortality or major ischaemic morbidity (myocardial infarction, stroke, pulmonary embolism, renal failure, bowel infarction) Secondary Endpoints; (i) 30-day mortality (ii) Ischaemic complications • Myocardial infarction • Stroke • Renal failure • Pulmonary embolism • Bowel infarction (iii) Bleeding complications • Major haemorrhage (re-operation for bleeding) • Cardiac tamponade • Number of transfused blood product units;Primary end point(s): The primary outcome is all cause mortality at 30 days following surgery. | — |
Countries
Italy, United Kingdom
Outcome results
None listed