CABG heart bypass surgery
Conditions
Interventions
On the morning of surgery patients are randomised to one of 4 groups:
Group 1 = Aspirin
Group 2 = Tranexamic acid
Group 3 = Aspirin plus tranexamic acid
Group 4 = Placebo
Sponsors
Alfred Hospital
Eligibility
Age
18 Years to 99 Years
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 70 years and over * Left ventricular impairment (fractional area change 150 *mol/l or creatinine clearance 25 kg/m2) * Pulmonary hypertension (mPAP >25 mmHg) * Peripheral vascular disease.
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite: 30-day mortality or major morbidity (myocardial infarction, cardiogenic shock, stroke, pulmonary embolism, cardiac tamponade). | — |
Secondary
| Measure | Time frame |
|---|---|
| Each of the above, plus blood transfusion, re-operation, respiratory failure, renal failure, serious wound infection, prolonged hospitalisation. | — |
Countries
Netherlands
Outcome results
None listed