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Completed

NCT Number: NCT03125681

Remote Ischemic Conditioning and Platelet Dysfunction

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

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Key information

Conditions

Platelet Function

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change of Multiplate ADPtest AUC

    Time frame: Baseline, at the end of surgery, postoperative day 1

    Area under the aggregation curve (AUC) after platelet stimulation with adenosine diphosphate

Secondary outcomes

  1. Change of Multiplate ASPItest AUC

    Time frame: Baseline, at the end of surgery, postoperative day 1

    Area under the aggregation curve (AUC) after platelet stimulation with arachidonic acid

  2. Change of Multiplate COLtest AUC

    Time frame: Baseline, at the end of surgery, postoperative day 1

    Area under the aggregation curve (AUC) after platelet stimulation with collagen

  3. Change of Rotational thromboelastometry EXTEM parameter

    Time frame: Baseline, at the end of surgery, postoperative day 1

    Screening test for the extrinsic haemostasis system

  4. Change of Rotational thromboelastometry FIBTEM parameter

    Time frame: Baseline, at the end of surgery, postoperative day 1

    Represents an EXTEM based assay for the fibrin part of the clot

  5. Rotational thromboelastometry INTEM parameter

    Time frame: Baseline, at the end of surgery, postoperative day 1

    Intrinsically activated rotational thrombelastometry

  6. Change of Rotational thromboelastometry HEPTEM parameter

    Time frame: Baseline, at the end of surgery, postoperative day 1

    Represents an INTEM assay performed in the presence of heparinase

  7. Amount of peri-operative bleeding and transfusion

    Time frame: At the end of surgery, postoperative day 1,2,3

    Amount of peri-operative bleeding and transfusion

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 24, 2017
Registry last updated
Apr 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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