Ischamic heart disease operated MedDRA version: 9.1 Level: LLT Classification code 10023024 Term: Ischaemic heart disease
Conditions
Interventions
Trade Name: ASPIRIN
Product Name: ASPIRIN
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Trade Name: Cyklokapron
Product Name:
Sponsors
University Hospitals Bristol NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: males and females 18 years and older. written informed consent. elective coronary artery surgery. Patient at increaed risk of major complications, defined by any of: age =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Poor English Clinician preference for antifibrinolytic urgent surgery for unstable symptoms active peptic ulceration allergy or contraindication to aspirin or tranexamic acid aspirin therapy within 5 days of surgery warfarin or clopidogril within 7 days of surgery GIIb/IIIa antagonists within 24 hours thrombocytopenia severe renal impairment creatinine clearance <25 history of thromboembolic disease pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Should aspirin therapy be routinely continued during coronary artery bypass grafting;Secondary Objective: Should Tranexamic acid be routinely used in all coronary artery bypass grafting operations;Primary end point(s): All cause 30 day mortality myocardial infarction pulmonary embolism stroke acute renal failure bowel infarction cardiac tamponade major haemorrhage requiring surgical re exploration | — |
Countries
United Kingdom
Outcome results
None listed