Remote Ischemic Conditioning and Platelet Dysfunction

Effect of Remote Ischemic Conditioning on Platelet Dysfunction Following Off-pump Coronary Artery Bypass Surgery

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

Study Overview

• Status: Completed
• Conditions: Platelet Function
• Intervention / Treatment: Procedure: Remote ischemic conditioning; Procedure: Control

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.

• 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: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: 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.
Placebo Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Multiplate ADPtest AUC	Area under the aggregation curve (AUC) after platelet stimulation with adenosine diphosphate	Baseline, at the end of surgery, postoperative day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Multiplate ASPItest AUC	Area under the aggregation curve (AUC) after platelet stimulation with arachidonic acid	Baseline, at the end of surgery, postoperative day 1
Change of Multiplate COLtest AUC	Area under the aggregation curve (AUC) after platelet stimulation with collagen	Baseline, at the end of surgery, postoperative day 1
Change of Rotational thromboelastometry EXTEM parameter	Screening test for the extrinsic haemostasis system	Baseline, at the end of surgery, postoperative day 1
Change of Rotational thromboelastometry FIBTEM parameter	Represents an EXTEM based assay for the fibrin part of the clot	Baseline, at the end of surgery, postoperative day 1
Rotational thromboelastometry INTEM parameter	Intrinsically activated rotational thrombelastometry	Baseline, at the end of surgery, postoperative day 1
Change of Rotational thromboelastometry HEPTEM parameter	Represents an INTEM assay performed in the presence of heparinase	Baseline, at the end of surgery, postoperative day 1
Amount of peri-operative bleeding and transfusion	Amount of peri-operative bleeding and transfusion	At the end of surgery, postoperative day 1,2,3

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: Principal Investigator: Yunseok Jeon, M.D., Ph. D., Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2017
• Primary Completion (Actual): January 31, 2019
• Study Completion (Actual): February 9, 2019

Study Registration Dates

• First Submitted: April 14, 2017
• First Submitted That Met QC Criteria: April 18, 2017
• First Posted (Actual): April 24, 2017

Study Record Updates

• Last Update Posted (Actual): April 4, 2019
• Last Update Submitted That Met QC Criteria: April 2, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: remote ischemic conditioning; off-pump coronary artery bypass surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia
• Other Study ID Numbers: RIPC_multiplate

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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