RIPC and Platelet Activation on Platelet Activation During Cardiopulmonary Bypass

Study Overview
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Brief Summary
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In this study, the investigators are going to investigate the effects of remote ischemic preconditioning on platelet activation in patients undergoing cardiac surgery with cardiopulmonary bypass.

Detailed Description
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Previous studies reported that remote ischemic conditioning reduce platelet activation in patients with coronary artery disease or patients undergoing ablation for atrial fibrillation. Cardiac surgery with cardiopulmonary bypass has been associated with platelet activation. In this randomized study, investigators are going to compare the effects of remote ischemic preconditioning (RIPC) on platelet activation using flow cytometry in patients undergoing cardiac surgery with cardiopulmonary bypass.

Official Title
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Effect of Remote Ischemic Preconditioning on Platelet Activation During Cardiac Surgery With Cardiopulmonary Bypass

Conditions
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Platelet Dysfunction

Intervention / Treatment
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* Device: Remote ischemic preconditioning
* Device: Sham control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing cardiac surgery with cardiopulmonary bypass Exclusion Criteria: Preoperative left ventricle ejection fraction < 30%, mechanical ventricular support Peripheral vascular disease Poorly controlled diabetes mellitus NSAIDs within 3 days iv heparin within 6 h low molecular weight heparin within 24 h platelet inhibitor within 24 h known thrombocytopenia End stage renal disease / hemodialysis Active infection Pregnancy

Ages Eligible for Study
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Minimum Age: 18 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Remote ischemic preconditioning<br>Remote ischemic conditioning after anesthesia induction - four cycles of 5 min of ischemia followed by 5 min of reperfusion by inflation to 200 mm Hg and deflation of a blood pressure cuff on the upper arm | Device: Remote ischemic preconditioning<br>* Four cycles of 5 min of ischemia, which is induced by a blood pressure cuff in the upper arm inflated to 200 mmHg, followed by 5 min of reperfusion, during which the cuff is deflated.<br>|
| Sham Comparator: Sham control<br>The same blood pressure cuff is placed around the upper arm, but the cuff is inflated to 10mm Hg. | Device: Sham control<br>* The same blood pressure cuff is placed around the upper arm, but the cuff is inflated to 10 mm Hg and ischemic preconditioning is not induced.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet activation measured by CD62P expression using flow cytometry | CD62P AUC (area under the curve) | During 3hour after cardiopulmonary bypass initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Platelet activation measured by CD63 expression using flow cytometry | CD63 AUC (area under the curve) | During 3hour after cardiopulmonary bypass initiation | 
| Platelet activation measured by monocyte-platelet aggregates (MPA) expression using flow cytometry | MPA AUC (area under the curve) | During 3hour after cardiopulmonary bypass initiation | 
| Platelet activation measured by PAC1 expression using flow cytometry | PAC1 AUC (area under the curve) | During 3hour after cardiopulmonary bypass initiation | 
| Platelet activation measured by platelet microparticles (PMP) expression using flow cytometry | PMP AUC (area under the curve) | During 3hour after cardiopulmonary bypass initiation | 
| ADPtest by Multiplate® platelet function analyser | ADPtest AU | 3hour after cardiopulmonary bypass initiation | 
| ASPItest by Multiplate® platelet function analyser | ASPItest AU | 3hour after cardiopulmonary bypass initiation | 
| COLtest by Multiplate® platelet function analyser | COLtest AU | 3hour after cardiopulmonary bypass initiation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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platelet activation, remote ischemic preconditioning