Remote Ischemic Conditioning and Platelet Dysfunction

Not Applicable

Completed

• Conditions: Platelet Function

• 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.

Study Timeline

• Study First Submitted: 2017-04-14
• Study First Submitted QC: 2017-04-18
• Study First Posted: 2017-04-24
• Study Start: 2017-05-11
• Primary Completion: 2019-01-31
• Study Completion: 2019-02-09
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-02
• Last Update Posted: 2019-04-04

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

Primary Outcome Measures

Name	Time	Method
Change of Multiplate ADPtest AUC	Baseline, at the end of surgery, postoperative day 1	Area under the aggregation curve (AUC) after platelet stimulation with adenosine diphosphate

Secondary Outcome Measures

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