Clinical trial NCT03125681: Remote Ischemic Conditioning and Platelet Dysfunction
Official title: Effect of Remote Ischemic Conditioning on Platelet Dysfunction Following Off-pump Coronary Artery Bypass Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Platelet Function
Keywords: remote ischemic conditioning
off-pump coronary artery bypass surgery
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2017-04-24
Enrollment: 58
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of Multiplate ADPtest AUC
timeFrame: Baseline, at the end of surgery, postoperative day 1
Secondary outcomes:
measure: Change of Multiplate ASPItest AUC
timeFrame: Baseline, at the end of surgery, postoperative day 1
measure: Change of Multiplate COLtest AUC
timeFrame: Baseline, at the end of surgery, postoperative day 1
measure: Change of Rotational thromboelastometry EXTEM parameter
timeFrame: Baseline, at the end of surgery, postoperative day 1
measure: Change of Rotational thromboelastometry FIBTEM parameter
timeFrame: Baseline, at the end of surgery, postoperative day 1
measure: Rotational thromboelastometry INTEM parameter
timeFrame: Baseline, at the end of surgery, postoperative day 1
measure: Change of Rotational thromboelastometry HEPTEM parameter
timeFrame: Baseline, at the end of surgery, postoperative day 1
measure: Amount of peri-operative bleeding and transfusion
timeFrame: At the end of surgery, postoperative day 1,2,3
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Yunseok Jeon, M.D., Ph. D.
role: PRINCIPAL_INVESTIGATOR
References: