Remote Ischemic Conditioning and Platelet Dysfunction

NCT ID: NCT03125681

Last Updated: 2019-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-11
• Study Completion Date: 2019-02-09

Brief Summary

The purpose of this study is to evaluate the effects of remote ischemic conditioning on platelet function during off-pump coronary artery bypass surgery.

Detailed Description

Remote ischemic conditioning (RIC) may affect platelet function. However, little is known about effect of RIC on platelet function during off-pump coronary artery bypass surgery. In this study investigators are going to perform RIC after anesthesia induction (remote ischemic pre-conditioning) and after completion of coronary anastomoses (remote ischemic post-conditioning), and compare platelet function parameters with control group.

Conditions

Platelet Function

Study Design

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

Study Groups

Remote ischemic conditioning

Applying pneumatic cuff on upper extremity (5 minutes cycles of limb ischemia and reperfusion with pneumatic cuff up to 200 mmHg repeated by four times) before and after coronary anastomoses.

Group Type: EXPERIMENTAL

Remote ischemic conditioning

Intervention Type: PROCEDURE

In the RIC group, RIC is performed before and after coronary anastomoses by 5 minutes limb ischemia and reperfusion with pneumatic cuff up to 200 mmHg repeated by four times.

Control

All the procedures were the same in the control group, except for the fact that the three-way stopcock between the pneumatic cuff and the cuff inflator was opened and therefore the cuff pressure did not increase.

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: PROCEDURE

In the control group, all the procedures will be same with RIC group, except for the fact that the three-way stopcock between the pneumatic cuff and the cuff inflator was opened and therefore the cuff pressure did not increase.

Interventions

Remote ischemic conditioning

In the RIC group, RIC is performed before and after coronary anastomoses by 5 minutes limb ischemia and reperfusion with pneumatic cuff up to 200 mmHg repeated by four times.

Intervention Type: PROCEDURE

Control

In the control group, all the procedures will be same with RIC group, except for the fact that the three-way stopcock between the pneumatic cuff and the cuff inflator was opened and therefore the cuff pressure did not increase.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 20 - 80 years of adult patient undergoing elective off-pump coronary artery bypass surgery

Exclusion Criteria

• Acute Myocardial Infarction
• Recent (<1 month) coronary angioplasty (percutaneous coronary intervention, PCI)
• Acute cerebrovascular ischemia (<6 months)
• Preoperative LV EF < 30%, mechanical ventricular support (IABP, VAD, ECMO)
• Peripheral vascular disease
• Poorly controlled diabetes mellitus
• Alzheimer's disease
• NSAIDs within 3 days
• iv heparin within 6 h
• low molecular weight heparin within 24 h
• platelet inhibitor within 24 h
• known thrombocytopenia
• renal failure / hemodialysis
• active infection
• preoperative bleeding diathesis
• redo-operation
• pregnancy

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 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, M.D., Ph. D.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

RIPC_multiplate

Identifier Type: -

Identifier Source: org_study_id