RIPC and Platelet Activation on Platelet Activation During Cardiopulmonary Bypass

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

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.

Study Overview

• Status: Completed
• Conditions: Platelet Dysfunction
• Intervention / Treatment: Device: Remote ischemic preconditioning; Device: Sham control

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 Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Device: Remote ischemic preconditioning; Four cycles of 5 min of ischemia, which is induced by a blood pressure cuff in the upper arm inflated to 200 mmHg, followed by 5 min of reperfusion, during which the cuff is deflated.
Sham Comparator: Sham control; The same blood pressure cuff is placed around the upper arm, but the cuff is inflated to 10mm Hg.	Device: Sham control; The same blood pressure cuff is placed around the upper arm, but the cuff is inflated to 10 mm Hg and ischemic preconditioning is not induced.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2018
• Primary Completion (Actual): August 5, 2019
• Study Completion (Actual): August 14, 2019

Study Registration Dates

• First Submitted: February 22, 2018
• First Submitted That Met QC Criteria: March 7, 2018
• First Posted (Actual): March 8, 2018

Study Record Updates

• Last Update Posted (Actual): October 15, 2019
• Last Update Submitted That Met QC Criteria: October 14, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: remote ischemic preconditioning; platelet activation
• Other Study ID Numbers: RIPC_platelet activation

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No