RIPC and Platelet Activation on Platelet Activation During Cardiopulmonary Bypass

NCT03458351 | Completed

• 1 other identifier: RIPC_platelet activation
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Platelet Dysfunction

Keywords

platelet activation; remote ischemic preconditioning

Outcome Measures

Primary Outcomes (1)

• Platelet activation measured by CD62P expression using flow cytometry

  CD62P AUC (area under the curve)

  During 3hour after cardiopulmonary bypass initiation

Secondary Outcomes (7)

• Platelet activation measured by CD63 expression using flow cytometry

  During 3hour after cardiopulmonary bypass initiation

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

  During 3hour after cardiopulmonary bypass initiation

• Platelet activation measured by PAC1 expression using flow cytometry

  During 3hour after cardiopulmonary bypass initiation

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

  During 3hour after cardiopulmonary bypass initiation

• ADPtest by Multiplate® platelet function analyser

  3hour after cardiopulmonary bypass initiation

Study Arms (2)

Remote ischemic preconditioning

ACTIVE COMPARATOR

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 control

SHAM COMPARATOR

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

Device: Sham control

Interventions

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.

Remote ischemic preconditioning

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.

Sham control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing cardiac surgery with cardiopulmonary bypass

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Study Officials

• Yunseok Jeon

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 22, 2018
• First Posted: March 8, 2018
• Study Start: March 28, 2018
• Primary Completion: August 5, 2019
• Study Completion: August 14, 2019
• Last Updated: October 15, 2019

Record last verified: 2019-10

Locations

KR (1)