Remote Ischemic Conditioning and Platelet Dysfunction

NCT03125681 | Completed DMC

• 1 other identifier: RIPC_multiplate
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Platelet Function

Keywords

remote ischemic conditioning; off-pump coronary artery bypass surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change of Multiplate ASPItest AUC

  Baseline, at the end of surgery, postoperative day 1

• Change of Multiplate COLtest AUC

  Baseline, at the end of surgery, postoperative day 1

• Change of Rotational thromboelastometry EXTEM parameter

  Baseline, at the end of surgery, postoperative day 1

• Change of Rotational thromboelastometry FIBTEM parameter

  Baseline, at the end of surgery, postoperative day 1

• Rotational thromboelastometry INTEM parameter

  Baseline, at the end of surgery, postoperative day 1

Study Arms (2)

Remote ischemic conditioning

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Interventions

Remote ischemic conditioning 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.

Remote ischemic conditioning

Control 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.

Control

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Study Officials

• Yunseok Jeon, M.D., Ph. D.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: April 24, 2017
• Study Start: May 11, 2017
• Primary Completion: January 31, 2019
• Study Completion: February 9, 2019
• Last Updated: April 4, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)