RIPC and Platelet Activation on Platelet Activation During Cardiopulmonary Bypass

NCT ID: NCT03458351

Last Updated: 2019-10-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-28
• Study Completion Date: 2019-08-14

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.

Conditions

Platelet Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Remote ischemic preconditioning

Intervention Type: DEVICE

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 10mm Hg.

Group Type: SHAM_COMPARATOR

Sham control

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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
• Pregnancy

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yunseok Jeon

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yunseok Jeon

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

RIPC_platelet activation

Identifier Type: -

Identifier Source: org_study_id