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CompletedNCT03458351Updated Oct 15, 2019

RIPC and Platelet Activation on Platelet Activation During Cardiopulmonary Bypass

An interventional study of Remote ischemic preconditioning and Sham control in Platelet Dysfunction, sponsored by Seoul National University Hospital. Completed at 1 site in South Korea. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-10-15.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
58
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Platelet Dysfunction

Keywords

  • platelet activation
  • remote ischemic preconditioning
03

In context

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,898 studies on the registry; 274 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients undergoing cardiac surgery with cardiopulmonary bypass

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
58 participants (actual)

Study arms

  • Active comparator
    Remote ischemic preconditioning

    Remote ischemic conditioning after anesthesia induction \- four cycles of 5 min of ischemia followed by 5 min of reperfusion by inflation to 200 mm Hg and deflation of a blood pressure cuff on the upper arm

    Device: Remote ischemic preconditioning

  • Sham comparator
    Sham control

    The same blood pressure cuff is placed around the upper arm, but the cuff is inflated to 10mm Hg.

    Device: Sham control

Interventions

  • DeviceRemote ischemic preconditioning

    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.

  • DeviceSham control

    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.

06

What researchers measure

Primary outcomes

  1. Platelet activation measured by CD62P expression using flow cytometry

    CD62P AUC (area under the curve)

    Time frame: During 3hour after cardiopulmonary bypass initiation

Secondary outcomes

  1. Platelet activation measured by CD63 expression using flow cytometry

    CD63 AUC (area under the curve)

    Time frame: During 3hour after cardiopulmonary bypass initiation

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

    MPA AUC (area under the curve)

    Time frame: During 3hour after cardiopulmonary bypass initiation

  3. Platelet activation measured by PAC1 expression using flow cytometry

    PAC1 AUC (area under the curve)

    Time frame: During 3hour after cardiopulmonary bypass initiation

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

    PMP AUC (area under the curve)

    Time frame: During 3hour after cardiopulmonary bypass initiation

  5. ADPtest by Multiplate® platelet function analyser

    ADPtest AU

    Time frame: 3hour after cardiopulmonary bypass initiation

  6. ASPItest by Multiplate® platelet function analyser

    ASPItest AU

    Time frame: 3hour after cardiopulmonary bypass initiation

  7. COLtest by Multiplate® platelet function analyser

    COLtest AU

    Time frame: 3hour after cardiopulmonary bypass initiation

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, 03080, South Korea
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03458351
Responsible party
Yunseok Jeon (Professor, Seoul National University Hospital) — Principal investigator
First posted
Mar 8, 2018
Start date
Mar 28, 2018
Primary completion
Aug 5, 2019
Completion
Aug 14, 2019
Last update
Oct 15, 2019

Study contacts

Yunseok Jeon
principal investigator · Seoul National University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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