Platelet Function
Conditions
Keywords
remote ischemic conditioning, off-pump coronary artery bypass surgery
Brief summary
The purpose of this study is to evaluate the effects of remote ischemic conditioning on platelet function during off-pump coronary artery bypass surgery.
Detailed description
Remote ischemic conditioning (RIC) may affect platelet function. However, little is known about effect of RIC on platelet function during off-pump coronary artery bypass surgery. In this study investigators are going to perform RIC after anesthesia induction (remote ischemic pre-conditioning) and after completion of coronary anastomoses (remote ischemic post-conditioning), and compare platelet function parameters with control group.
Interventions
PROCEDURERemote ischemic conditioning
In the RIC group, RIC is performed before and after coronary anastomoses by 5 minutes limb ischemia and reperfusion with pneumatic cuff up to 200 mmHg repeated by four times.
PROCEDUREControl
In the control group, all the procedures will be same with RIC group, except for the fact that the three-way stopcock between the pneumatic cuff and the cuff inflator was opened and therefore the cuff pressure did not increase.
Sponsors
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 20 - 80 years of adult patient undergoing elective off-pump coronary artery bypass surgery
Exclusion criteria
* Acute Myocardial Infarction * Recent (\<1 month) coronary angioplasty (percutaneous coronary intervention, PCI) * Acute cerebrovascular ischemia (\<6 months) * Preoperative LV EF \< 30%, mechanical ventricular support (IABP, VAD, ECMO) * Peripheral vascular disease * Poorly controlled diabetes mellitus * Alzheimer's disease * NSAIDs within 3 days * iv heparin within 6 h * low molecular weight heparin within 24 h * platelet inhibitor within 24 h * known thrombocytopenia * renal failure / hemodialysis * active infection * preoperative bleeding diathesis * redo-operation * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Multiplate ADPtest AUC | Baseline, at the end of surgery, postoperative day 1 | Area under the aggregation curve (AUC) after platelet stimulation with adenosine diphosphate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Multiplate ASPItest AUC | Baseline, at the end of surgery, postoperative day 1 | Area under the aggregation curve (AUC) after platelet stimulation with arachidonic acid |
| Change of Multiplate COLtest AUC | Baseline, at the end of surgery, postoperative day 1 | Area under the aggregation curve (AUC) after platelet stimulation with collagen |
| Change of Rotational thromboelastometry EXTEM parameter | Baseline, at the end of surgery, postoperative day 1 | Screening test for the extrinsic haemostasis system |
| Amount of peri-operative bleeding and transfusion | At the end of surgery, postoperative day 1,2,3 | Amount of peri-operative bleeding and transfusion |
| Rotational thromboelastometry INTEM parameter | Baseline, at the end of surgery, postoperative day 1 | Intrinsically activated rotational thrombelastometry |
| Change of Rotational thromboelastometry HEPTEM parameter | Baseline, at the end of surgery, postoperative day 1 | Represents an INTEM assay performed in the presence of heparinase |
| Change of Rotational thromboelastometry FIBTEM parameter | Baseline, at the end of surgery, postoperative day 1 | Represents an EXTEM based assay for the fibrin part of the clot |
Countries
South Korea
Outcome results
None listed