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Completed

NCT Number: NCT03458351

RIPC and Platelet Activation on Platelet Activation During Cardiopulmonary Bypass

In this study, the investigators are going to investigate the effects of remote ischemic preconditioning on platelet activation in patients undergoing cardiac surgery with cardiopulmonary bypass.

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Key information

Conditions

Platelet Dysfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

Previous studies reported that remote ischemic conditioning reduce platelet activation in patients with coronary artery disease or patients undergoing ablation for atrial fibrillation. Cardiac surgery with cardiopulmonary bypass has been associated with platelet activation. In this randomized study, investigators are going to compare the effects of remote ischemic preconditioning (RIPC) on platelet activation using flow cytometry in patients undergoing cardiac surgery with cardiopulmonary bypass.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients undergoing cardiac surgery with cardiopulmonary bypass

Exclusion criteria

  • Preoperative left ventricle ejection fraction < 30%, mechanical ventricular support
  • Peripheral vascular disease
  • Poorly controlled diabetes mellitus
  • NSAIDs within 3 days
  • iv heparin within 6 h
  • low molecular weight heparin within 24 h
  • platelet inhibitor within 24 h
  • known thrombocytopenia
  • End stage renal disease / hemodialysis
  • Active infection
  • Pregnancy

Treatment and study plan

Remote ischemic preconditioning

Device

Four cycles of 5 min of ischemia, which is induced by a blood pressure cuff in the upper arm inflated to 200 mmHg, followed by 5 min of reperfusion, during which the cuff is deflated.

sham control

Device

The same blood pressure cuff is placed around the upper arm, but the cuff is inflated to 10 mm Hg and ischemic preconditioning is not induced.

Primary outcomes

  1. Platelet activation measured by CD62P expression using flow cytometry

    Time frame: During 3hour after cardiopulmonary bypass initiation

    CD62P AUC (area under the curve)

Secondary outcomes

  1. Platelet activation measured by CD63 expression using flow cytometry

    Time frame: During 3hour after cardiopulmonary bypass initiation

    CD63 AUC (area under the curve)

  2. Platelet activation measured by monocyte-platelet aggregates (MPA) expression using flow cytometry

    Time frame: During 3hour after cardiopulmonary bypass initiation

    MPA AUC (area under the curve)

  3. Platelet activation measured by PAC1 expression using flow cytometry

    Time frame: During 3hour after cardiopulmonary bypass initiation

    PAC1 AUC (area under the curve)

  4. Platelet activation measured by platelet microparticles (PMP) expression using flow cytometry

    Time frame: During 3hour after cardiopulmonary bypass initiation

    PMP AUC (area under the curve)

  5. ADPtest by Multiplate® platelet function analyser

    Time frame: 3hour after cardiopulmonary bypass initiation

    ADPtest AU

  6. ASPItest by Multiplate® platelet function analyser

    Time frame: 3hour after cardiopulmonary bypass initiation

    ASPItest AU

  7. COLtest by Multiplate® platelet function analyser

    Time frame: 3hour after cardiopulmonary bypass initiation

    COLtest AU

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Effect of Remote Ischemic Preconditioning on Platelet Activation During Cardiac Surgery With Cardiopulmonary Bypass

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Mar 8, 2018
Registry last updated
Oct 15, 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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