Remote Ischemic Conditioning and Platelet Dysfunction

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Remote Ischemic Conditioning on Platelet Dysfunction Following Off-pump Coronary Artery Bypass Surgery

Conditions
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Platelet Function

Intervention / Treatment
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* Procedure: Remote ischemic conditioning
* Procedure: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remote ischemic conditioning<br>Applying pneumatic cuff on upper extremity (5 minutes cycles of limb ischemia and reperfusion with pneumatic cuff up to 200 mmHg repeated by four times) before and after coronary anastomoses. | Procedure: Remote ischemic conditioning<br>* 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.<br>|
| Placebo Comparator: Control<br>All the procedures were the same in the control 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. | Procedure: Control<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Multiplate ADPtest AUC | Area under the aggregation curve (AUC) after platelet stimulation with adenosine diphosphate | Baseline, at the end of surgery, postoperative day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Multiplate ASPItest AUC | Area under the aggregation curve (AUC) after platelet stimulation with arachidonic acid | Baseline, at the end of surgery, postoperative day 1 | 
| Change of Multiplate COLtest AUC | Area under the aggregation curve (AUC) after platelet stimulation with collagen | Baseline, at the end of surgery, postoperative day 1 | 
| Change of Rotational thromboelastometry EXTEM parameter | Screening test for the extrinsic haemostasis system | Baseline, at the end of surgery, postoperative day 1 | 
| Change of Rotational thromboelastometry FIBTEM parameter | Represents an EXTEM based assay for the fibrin part of the clot | Baseline, at the end of surgery, postoperative day 1 | 
| Rotational thromboelastometry INTEM parameter | Intrinsically activated rotational thrombelastometry | Baseline, at the end of surgery, postoperative day 1 | 
| Change of Rotational thromboelastometry HEPTEM parameter | Represents an INTEM assay performed in the presence of heparinase | Baseline, at the end of surgery, postoperative day 1 | 
| Amount of peri-operative bleeding and transfusion | Amount of peri-operative bleeding and transfusion | At the end of surgery, postoperative day 1,2,3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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remote ischemic conditioning, off-pump coronary artery bypass surgery