Remote Ischemic Conditioning and Platelet Dysfunction

Platelet Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03125681
• Other study ID #: RIPC_multiplate
• Status: Completed
• Phase: N/A
• Start date: May 11, 2017
• Est. completion date: February 9, 2019

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: February 9, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Platelet Function

Intervention

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.
• 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.

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	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	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
Secondary	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
Secondary	Change of Rotational thromboelastometry EXTEM parameter	Screening test for the extrinsic haemostasis system	Baseline, at the end of surgery, postoperative day 1
Secondary	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
Secondary	Rotational thromboelastometry INTEM parameter	Intrinsically activated rotational thrombelastometry	Baseline, at the end of surgery, postoperative day 1
Secondary	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
Secondary	Amount of peri-operative bleeding and transfusion	Amount of peri-operative bleeding and transfusion	At the end of surgery, postoperative day 1,2,3