Should low-dose aspirin be continued up until the day of CABG or OPCAB surgery?Should TxA be used for all at-risk CABG or OPCAB surgery?
ID
Source
Brief title
Condition
- Coronary artery disorders
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Composite: 30-day mortality or major morbidity (myocardial infarction,
cardiogenic shock, stroke, pulmonary embolism, cardiac tamponade).
Secondary outcome
Each of the above, plus blood transfusion, re-operation, respiratory failure,
renal failure, serious wound infection, prolonged hospitalisation.
Background summary
There are more than 10,000 cardiac surgery cases done each year in The
Netherlands. About 5% have a serious complication or die; this adds
substantially to healthcare costs. Cardiac surgery activates platelets and
coagulation factors, and the fibrinolytic pathway. Excessive bleeding is
common. This may require surgical re-exploration and increases morbidity and
mortality. Recent aspirin exposure increases surgical bleeding. It is routine
practice in most cardiac surgical centres for aspirin to be ceased 1 wk before
elective cardiac surgery. But a recent landmark study found that aspirin had a
lower mortality, as well as less stroke, renal failure and bowel infarction
(all P<0.01), presumably because of its anti-thrombogenic effects.
Another drug, Tranexamic Acid (TxA), is sometimes used to reduce bleeding after
cardiac surgery. It works by blocking the activation fibrinolysis ("clot
breakdown") that often occurs during bypass and surgery. It can block the
bleeding risk associate with aspirin, and does not increase thrombotic risk.
Meta-analyses of trials have shown that antifibrinolytic therapy reduces blood
loss, need for blood transfusion and re-operation for bleeding in cardiac
surgery. Such therapy may also reduce mortality. Large outcome trial data are
lacking.
Study objective
Should low-dose aspirin be continued up until the day of CABG or OPCAB surgery?
Should TxA be used for all at-risk CABG or OPCAB surgery?
Study design
Large, multi-centre, prospective,randomised, double blind, factorial trial.
Patients will be randomly allocated to aspirin, Tranexamic Acid, aspirin +
Tranexamic Acid or placebo.
Intervention
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
Study burden and risks
Patients get the usual care around their CABG procedure. The use of aspirin and
Tranexamic Acid is standard of care in the UMC Utrecht. Sampling of blood for
study purposes is combined with regular blood sampling. Participation is not
causing extra burden for the patient.
Commercial Road 55
Melbourne Victoria 3004
AU
Commercial Road 55
Melbourne Victoria 3004
AU
Listed location countries
Age
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 <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.
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 <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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | ACTRN 12605000555651 |
| CCMO | NL39627.041.13 |