RIPC and Platelet Activation on Platelet Activation During Cardiopulmonary Bypass

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03458351

Enrollment

Registered

2018-03-08

Start date

2018-03-28

Completion date

2019-08-14

Last updated

2019-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Platelet Dysfunction

Keywords

platelet activation, remote ischemic preconditioning

Brief 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.

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.

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Platelet activation measured by CD62P expression using flow cytometry	During 3hour after cardiopulmonary bypass initiation	CD62P AUC (area under the curve)

Secondary

Measure	Time frame	Description
COLtest by Multiplate® platelet function analyser	3hour after cardiopulmonary bypass initiation	COLtest AU
Platelet activation measured by PAC1 expression using flow cytometry	During 3hour after cardiopulmonary bypass initiation	PAC1 AUC (area under the curve)
Platelet activation measured by platelet microparticles (PMP) expression using flow cytometry	During 3hour after cardiopulmonary bypass initiation	PMP AUC (area under the curve)
ASPItest by Multiplate® platelet function analyser	3hour after cardiopulmonary bypass initiation	ASPItest AU
Platelet activation measured by CD63 expression using flow cytometry	During 3hour after cardiopulmonary bypass initiation	CD63 AUC (area under the curve)
Platelet activation measured by monocyte-platelet aggregates (MPA) expression using flow cytometry	During 3hour after cardiopulmonary bypass initiation	MPA AUC (area under the curve)
ADPtest by Multiplate® platelet function analyser	3hour after cardiopulmonary bypass initiation	ADPtest AU

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026