Effect of Remote Ischemic Conditioning on Platelet Dysfunction Following Off-pump Coronary Artery Bypass Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Change of Multiplate ADPtest AUC
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Remote ischemic conditioning
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.
Intervention: Remote ischemic conditioning (Procedure)
Control
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.
Intervention: Control (Procedure)
Outcomes
Primary Outcomes
Change of Multiplate ADPtest AUC
Time Frame: Baseline, at the end of surgery, postoperative day 1
Area under the aggregation curve (AUC) after platelet stimulation with adenosine diphosphate
Secondary Outcomes
- Change of Rotational thromboelastometry FIBTEM parameter(Baseline, at the end of surgery, postoperative day 1)
- Rotational thromboelastometry INTEM parameter(Baseline, at the end of surgery, postoperative day 1)
- Change of Rotational thromboelastometry HEPTEM parameter(Baseline, at the end of surgery, postoperative day 1)
- Amount of peri-operative bleeding and transfusion(At the end of surgery, postoperative day 1,2,3)
- Change of Multiplate ASPItest AUC(Baseline, at the end of surgery, postoperative day 1)
- Change of Multiplate COLtest AUC(Baseline, at the end of surgery, postoperative day 1)
- Change of Rotational thromboelastometry EXTEM parameter(Baseline, at the end of surgery, postoperative day 1)
Investigators
Yunseok Jeon
Professor
Seoul National University Hospital