RIPC and Platelet Activation on Platelet Activation During Cardiopulmonary Bypass

Platelet Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03458351
• Other study ID #: RIPC_platelet activation
• Status: Completed
• Phase: N/A
• Start date: March 28, 2018
• Est. completion date: August 14, 2019

Study information

• Verified date: October 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: August 14, 2019
• Est. primary completion date: August 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Platelet Dysfunction

Intervention

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 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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet activation measured by CD62P expression using flow cytometry	CD62P AUC (area under the curve)	During 3hour after cardiopulmonary bypass initiation
Secondary	Platelet activation measured by CD63 expression using flow cytometry	CD63 AUC (area under the curve)	During 3hour after cardiopulmonary bypass initiation
Secondary	Platelet activation measured by monocyte-platelet aggregates (MPA) expression using flow cytometry	MPA AUC (area under the curve)	During 3hour after cardiopulmonary bypass initiation
Secondary	Platelet activation measured by PAC1 expression using flow cytometry	PAC1 AUC (area under the curve)	During 3hour after cardiopulmonary bypass initiation
Secondary	Platelet activation measured by platelet microparticles (PMP) expression using flow cytometry	PMP AUC (area under the curve)	During 3hour after cardiopulmonary bypass initiation
Secondary	ADPtest by Multiplate® platelet function analyser	ADPtest AU	3hour after cardiopulmonary bypass initiation
Secondary	ASPItest by Multiplate® platelet function analyser	ASPItest AU	3hour after cardiopulmonary bypass initiation
Secondary	COLtest by Multiplate® platelet function analyser	COLtest AU	3hour after cardiopulmonary bypass initiation