The analysis is performed of thrombocyte function before, during and and after CABG surgery with dedicated tests as Light Transmission Aggregometry(LTA), thromboelastography (TEG), Multiple Electrode Aggregrometry (MEA) en Platelet Function Analyzer…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Cardiac therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Outcome if the different labortory tests of platelet function
Blood loos during and within 24 hours after the surgical procedrue
Transfused number of units during and within 24 hours after the surgical
procedure
Secondary outcome
Correlation between the different thrombocyte function tests in the two studied
populations
Background summary
Cardiothoracal surgical procedures as coronary artery bypass grafting (CABG)
are frequently accompanied by transfusions. Several studies have shown that
extensive transfusion during and after the procedure is associated with a
reduced prognosis of the patient. Risk factors that attribute to this are
transfusion reactions, infections and immune suppression.
Several procedural issues (use of extracorporal circulation, hypothermia,
haemodilution etc) reduce the thrombocyte function during the operation.
Moreover, use of aspirin and clopidogrel result in an acquired
thrombocytopathy, additionally reducing the functionality of the thrombocytes.
To prevent bleeding events thrombocyte concentrates are frequently transfused,
predominantly in patients using clopidogrel. The transfusion is based on
estimated and expected blood loss and not on laboratory testing of thrombocyte
function. As the response of thrombocyte function on clopidogrel is highly
variable, it is expected that many patiënt are transfused without adequate
indication.
Nowadays several laboratory techniques are available that can be employed to
estimate the thrombocyte function during the CABG-procedure. Established
techniques are Light Transmission Aggregometry (LTA), thromboelastografy (TEG)
and Multiple Electrode Aggregrometrie (MEA). Also, a new application has
recently been launched for the Platelet Function Analyzer (PFA100) to
specifically determine the effect of clopidogrel on platelet function. These
techniques can potentially be used to measure thrombocyte function during the
CABG-procedure and to base an effective thrombocyte transfusion decisions on,
for an optimal patient care.
Study objective
The analysis is performed of thrombocyte function before, during and and after
CABG surgery with dedicated tests as Light Transmission Aggregometry(LTA),
thromboelastography (TEG), Multiple Electrode Aggregrometry (MEA) en Platelet
Function Analyzer (PFA100) . De predictive value is determined of the separate
testing procedures for peri- en post-operative blood loss and the number of
transfused blood products. Calculations are performed in a patient group that
has been treated with clopidogrel until the day of the procedure (in
combination with aspirin) and in a patient group that has not been treated with
clopidogrel for at least 5 days before the procedure and has only been treated
with aspirin.
Study design
Monocenter, prospective, observational investigation
Study burden and risks
The burden during the study exists of blood sampling from mostly an arterial
line on tree time points:
1. Before start of the surgical procedure.
2. Meteen Immediately after the surgical procedure after antagonisation of
heparin
3. Later after the surgical procedure after arrival at the ICU
Michelangelolaan 2
5602 EJ
NL
Michelangelolaan 2
5602 EJ
NL
Listed location countries
Age
Inclusion criteria
Elective CABG-procedure with use of extracorporale circulation
Group 1: Minimum of 5 days use of clopidogrel and aspirin until day of procedure.
Group 2: Minimum of 5 days use of aspirin until the day of procedure, but no clopidogrel use for at least 5 days prior to the procedure.
Exclusion criteria
Use of coumarines or (low molecular weight) heparin
Clinical or laboratory signs of hemorrhagic diathesis
Cardiac failure
Renal insufficiency or dialysis
Liver failure
Chronic alcoholism
Age <18 years
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 |
---|---|
CCMO | NL32534.060.10 |