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Clinical Trials/NCT03458351
NCT03458351
Completed
Not Applicable

Effect of Remote Ischemic Preconditioning on Platelet Activation During Cardiac Surgery With Cardiopulmonary Bypass

Seoul National University Hospital1 site in 1 country58 target enrollmentMarch 28, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Platelet Dysfunction
Sponsor
Seoul National University Hospital
Enrollment
58
Locations
1
Primary Endpoint
Platelet activation measured by CD62P expression using flow cytometry
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 28, 2018
End Date
August 14, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yunseok Jeon

Professor

Seoul National University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Platelet activation measured by CD62P expression using flow cytometry

Time Frame: During 3hour after cardiopulmonary bypass initiation

CD62P AUC (area under the curve)

Secondary Outcomes

  • ASPItest by Multiplate® platelet function analyser(3hour after cardiopulmonary bypass initiation)
  • Platelet activation measured by platelet microparticles (PMP) expression using flow cytometry(During 3hour after cardiopulmonary bypass initiation)
  • ADPtest by Multiplate® platelet function analyser(3hour after cardiopulmonary bypass initiation)
  • COLtest by Multiplate® platelet function analyser(3hour after cardiopulmonary bypass initiation)
  • Platelet activation measured by CD63 expression using flow cytometry(During 3hour after cardiopulmonary bypass initiation)
  • Platelet activation measured by monocyte-platelet aggregates (MPA) expression using flow cytometry(During 3hour after cardiopulmonary bypass initiation)
  • Platelet activation measured by PAC1 expression using flow cytometry(During 3hour after cardiopulmonary bypass initiation)

Study Sites (1)

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