To investigate if the interruption of the clopidogrel is necessary before CABG in order to prevent bleeding and other complications, and if so, which is the safe time interval to proceed with surgery. To asses the predictive value of the TEG clot…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Cardiac therapeutic procedures
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Blood loss, transfusions and rethoracotomies.
Predictive value of TEG
Secondary outcome
Death, myocardial infarction, stroke, respiratory failure, renal failure
requiring dialysis, mediastinitis, wound infection, readmission rates within 30
days from discharge, and ICU and hospital lengths of stay
Background summary
By blockade of the platelet ADP receptor, clopidogrel inhibits the binding of
fibrinogen to the platelet GPIIb/IIIa receptor complex, thereby preventing
platelet aggregation from ADP stimulation.
Some authors suggest that the platelet function is completely recovered in 7
days after stopping clopidogrel in healthy subjects. Other researches suggest
full recovery of platelet function in 3 to 5 days.
In previous studies, mainly retrospective, it is suggested that the risk of
bleeding, blood transfusion and rethoracotomies due to defective coagulation
and platelet dysfunction is increased.
In a recent prospective randomized trial it has been demonstrated that the
strategy of continuing aspirin and clopidogrel therapy in combination with
intraoperative aprotinine leads to decrease blood loss and blood transfusion
requirement compared with stopping therapy with clopidogrel 5 days before
surgery.
This finding indicates that surgery does not have to be delayed for this group
of patients.
For a more specific determination of coagulation abnormality we will use
thromboelastogram (TEG) measurements. These measurements, correlated with the
post- surgical blood loss and use of blood products, will help us to asses the
predictive value of the TEG clot strength in postoperative bleeding in patients
using Clopidogrel.
Study objective
To investigate if the interruption of the clopidogrel is necessary before CABG
in order to prevent bleeding and other complications, and if so, which is the
safe time interval to proceed with surgery. To asses the predictive value of
the TEG clot strength in postoperative bleeding in patients using Clopidogrel.
Study design
A prospective, randomized mono- center study
Study burden and risks
In this trial no changes are made to the standard treatment and care of the
patient. Only 1 additional venapunction will be made pre-operatively. Since
there are many procedures with respect to the cancellation of clopidogrel
before surgery, we assume that there are no additional risks when participating
in this trial.
Michelangelolaan 2
5623 EJ Eindhoven
Nederland
Michelangelolaan 2
5623 EJ Eindhoven
Nederland
Listed location countries
Age
Inclusion criteria
Patients who are using clopidogrel at least 5 days before surgery with a dose of 75mg clopidogrel without loading dose, with or without concomitant use of aspirin. Or patients who received a loading dose of 300-600mg clopidogrel 24 hours before CABG, with or without concomitant use of aspirin
Exclusion criteria
concomitant use of coumarine/heparine derivates; pre-existing bleeding disorders; thrombocytopenia; renal and hepatic failure; end-stage heart failure; emergency bypass surgery; concomitant valvular or other cardiac procedures; re-operation; off-pump CABG
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| CCMO | NL11435.060.06 |