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Remote Ischemic Conditioning and Platelet Dysfunction

Primary Purpose

Platelet Function

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Remote ischemic conditioning
Control
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Platelet Function focused on measuring remote ischemic conditioning, off-pump coronary artery bypass surgery

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Remote ischemic conditioning

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change of Multiplate ADPtest AUC
Area under the aggregation curve (AUC) after platelet stimulation with adenosine diphosphate

Secondary Outcome Measures

Change of Multiplate ASPItest AUC
Area under the aggregation curve (AUC) after platelet stimulation with arachidonic acid
Change of Multiplate COLtest AUC
Area under the aggregation curve (AUC) after platelet stimulation with collagen
Change of Rotational thromboelastometry EXTEM parameter
Screening test for the extrinsic haemostasis system
Change of Rotational thromboelastometry FIBTEM parameter
Represents an EXTEM based assay for the fibrin part of the clot
Rotational thromboelastometry INTEM parameter
Intrinsically activated rotational thrombelastometry
Change of Rotational thromboelastometry HEPTEM parameter
Represents an INTEM assay performed in the presence of heparinase
Amount of peri-operative bleeding and transfusion
Amount of peri-operative bleeding and transfusion

Full Information

First Posted
April 14, 2017
Last Updated
April 2, 2019
Sponsor
Seoul National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03125681
Brief Title
Remote Ischemic Conditioning and Platelet Dysfunction
Official Title
Effect of Remote Ischemic Conditioning on Platelet Dysfunction Following Off-pump Coronary Artery Bypass Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
May 11, 2017 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
February 9, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Platelet Function
Keywords
remote ischemic conditioning, off-pump coronary artery bypass surgery

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remote ischemic conditioning
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Remote ischemic conditioning
Intervention Description
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
Intervention Name(s)
Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Multiplate ADPtest AUC
Description
Area under the aggregation curve (AUC) after platelet stimulation with adenosine diphosphate
Time Frame
Baseline, at the end of surgery, postoperative day 1
Secondary Outcome Measure Information:
Title
Change of Multiplate ASPItest AUC
Description
Area under the aggregation curve (AUC) after platelet stimulation with arachidonic acid
Time Frame
Baseline, at the end of surgery, postoperative day 1
Title
Change of Multiplate COLtest AUC
Description
Area under the aggregation curve (AUC) after platelet stimulation with collagen
Time Frame
Baseline, at the end of surgery, postoperative day 1
Title
Change of Rotational thromboelastometry EXTEM parameter
Description
Screening test for the extrinsic haemostasis system
Time Frame
Baseline, at the end of surgery, postoperative day 1
Title
Change of Rotational thromboelastometry FIBTEM parameter
Description
Represents an EXTEM based assay for the fibrin part of the clot
Time Frame
Baseline, at the end of surgery, postoperative day 1
Title
Rotational thromboelastometry INTEM parameter
Description
Intrinsically activated rotational thrombelastometry
Time Frame
Baseline, at the end of surgery, postoperative day 1
Title
Change of Rotational thromboelastometry HEPTEM parameter
Description
Represents an INTEM assay performed in the presence of heparinase
Time Frame
Baseline, at the end of surgery, postoperative day 1
Title
Amount of peri-operative bleeding and transfusion
Description
Amount of peri-operative bleeding and transfusion
Time Frame
At the end of surgery, postoperative day 1,2,3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yunseok Jeon, M.D., Ph. D.
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Remote Ischemic Conditioning and Platelet Dysfunction

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