RIPC and Platelet Activation on Platelet Activation During Cardiopulmonary Bypass

Not Applicable

Completed

• Conditions: Platelet Dysfunction
• Interventions: Device: Remote ischemic preconditioning; Device: Sham control

• Registration Number: NCT03458351
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-02-22
• Study First Submitted QC: 2018-03-07
• Study First Posted: 2018-03-08
• Study Start: 2018-03-28
• Primary Completion: 2019-08-05
• Study Completion: 2019-08-14
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-14
• Last Update Posted: 2019-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remote ischemic preconditioning	Remote ischemic preconditioning	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
Sham control	Sham control	The same blood pressure cuff is placed around the upper arm, but the cuff is inflated to 10mm Hg.

Primary Outcome Measures

Name	Time	Method
Platelet activation measured by CD62P expression using flow cytometry	During 3hour after cardiopulmonary bypass initiation	CD62P AUC (area under the curve)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of