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Remote Ischemic Conditioning and Platelet Dysfunction

Not Applicable
Completed
Conditions
Platelet Function
Interventions
Procedure: Remote ischemic conditioning
Procedure: Control
Registration Number
NCT03125681
Lead Sponsor
Seoul National University Hospital
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
58
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Remote ischemic conditioningRemote ischemic conditioningApplying 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.
ControlControlAll 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.
Primary Outcome Measures
NameTimeMethod
Change of Multiplate ADPtest AUCBaseline, at the end of surgery, postoperative day 1

Area under the aggregation curve (AUC) after platelet stimulation with adenosine diphosphate

Secondary Outcome Measures
NameTimeMethod
Change of Multiplate ASPItest AUCBaseline, at the end of surgery, postoperative day 1

Area under the aggregation curve (AUC) after platelet stimulation with arachidonic acid

Change of Multiplate COLtest AUCBaseline, at the end of surgery, postoperative day 1

Area under the aggregation curve (AUC) after platelet stimulation with collagen

Change of Rotational thromboelastometry EXTEM parameterBaseline, at the end of surgery, postoperative day 1

Screening test for the extrinsic haemostasis system

Change of Rotational thromboelastometry HEPTEM parameterBaseline, at the end of surgery, postoperative day 1

Represents an INTEM assay performed in the presence of heparinase

Change of Rotational thromboelastometry FIBTEM parameterBaseline, at the end of surgery, postoperative day 1

Represents an EXTEM based assay for the fibrin part of the clot

Rotational thromboelastometry INTEM parameterBaseline, at the end of surgery, postoperative day 1

Intrinsically activated rotational thrombelastometry

Amount of peri-operative bleeding and transfusionAt the end of surgery, postoperative day 1,2,3

Amount of peri-operative bleeding and transfusion

Trial Locations

Locations (1)

Seoul National University Hospital

🇰🇷

Seoul, Korea, Republic of

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