Effects of Low Dose Aspirin Pre-treatment on Platelet Activation Undergoing Off-pump Coronary Artery Bypass Surgery

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Drug: aspirin discontinuation; Drug: aspirin continuation

• Registration Number: NCT02209909
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Platelet activation after off pump coronary artery bypass (OPCAB) surgery may affect thrombus formation. The purpose of this study is to assess the effects of preoperative continuation of aspirin on platelet activation after off pump coronary artery bypass surgery.

Detailed Description

Patients undergoing OPCAB surgery will be randomized to continue preoperative aspirin or discontinue aspirin before surgery.

Platelet activation can be evaluated by measuring platelet p-selectin using flowcytometry. In this study, we will compare platelet-activated markers and conventional coagulation tests.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-31
• Status Verified: 2014-08
• Study First Submitted QC: 2014-08-05
• Study First Posted: 2014-08-06
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2016-04-20
• Last Update Posted: 2016-04-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

• age : 20-80
• elective OPCAB
• informed consent

Read More

Exclusion Criteria

• coagulation disorder
• emergency operation, re-operation
• co-existing valvular disease
• less than 6 months after cerebral vascular accident
• heparin induced thrombocytopenia
• heparin resistance
• menstrual phase
• preoperative cardiopulmonary bypass, continuous veno-veno hemofiltration, intra-aortic balloon pump application
• less than 12 months after myocardiac infarction
• less than 10 days after unstable angina
• less than 30 days after percutaneous coronary intervention
• less than 6 wks after bare metal stent insertion
• less than 12 months after drug eluting stent insertion

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aspirin discontinuation	aspirin discontinuation	Intervention: Low-dose aspirin is stopped more than 4 days before OPCAB surgery in the aspirin discontinuation group.
aspirin continuation	aspirin continuation	Intervention : Low-dose aspirin (\< 100mg/day) is used before OPCAB surgery in the aspirin continuation group.

Primary Outcome Measures

Name	Time	Method
change from baseline in platelet p-selectin at 48 hours after operation	after induction of anesthesia(baseline), at the time of end of operation, 24 hour after operation, 48hr after operation	Primary outcome is expression of platelet p-selectin measured by flowcytometry 48 hours after OPCAB surgery in both groups.

Secondary Outcome Measures

Name	Time	Method
change from baseline in conventional coagulation tests at the time of end of operation, 24 hour after operation, and 48hr after operation	after induction of anesthesia(baseline), at the time of end of operation, 24 hour after operation, 48hr after operation	prothrombin time (international normalized ratio), activated partial thromboplastin time, fibrinogen

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of