Clinical trial NCT03458351: RIPC and Platelet Activation on Platelet Activation During Cardiopulmonary Bypass
Official title: Effect of Remote Ischemic Preconditioning on Platelet Activation During Cardiac Surgery With Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Platelet Dysfunction
Keywords: platelet activation
remote ischemic preconditioning
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-03-08
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Platelet activation measured by CD62P expression using flow cytometry
timeFrame: During 3hour after cardiopulmonary bypass initiation
Secondary outcomes:
measure: Platelet activation measured by CD63 expression using flow cytometry
timeFrame: During 3hour after cardiopulmonary bypass initiation
measure: Platelet activation measured by monocyte-platelet aggregates (MPA) expression using flow cytometry
timeFrame: During 3hour after cardiopulmonary bypass initiation
measure: Platelet activation measured by PAC1 expression using flow cytometry
timeFrame: During 3hour after cardiopulmonary bypass initiation
measure: Platelet activation measured by platelet microparticles (PMP) expression using flow cytometry
timeFrame: During 3hour after cardiopulmonary bypass initiation
measure: ADPtest by Multiplate® platelet function analyser
timeFrame: 3hour after cardiopulmonary bypass initiation
measure: ASPItest by Multiplate® platelet function analyser
timeFrame: 3hour after cardiopulmonary bypass initiation
measure: COLtest by Multiplate® platelet function analyser
timeFrame: 3hour after cardiopulmonary bypass initiation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Yunseok Jeon
role: PRINCIPAL_INVESTIGATOR
References: