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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Masking: Double (Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: September 2015

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.

Interventions

  • Drug: aspirin continuation
    • Patients are randomized to continue aspirin before OPCAB surgery.
  • Drug: aspirin discontinuation
    • Patients are randomized to discontinue aspirin more than 4 days before OPCAB surgery.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • change from baseline in platelet p-selectin at 48 hours after operation
    • Time Frame: 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 Measures

  • change from baseline in conventional coagulation tests at the time of end of operation, 24 hour after operation, and 48hr after operation
    • Time Frame: 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

Participating in This Clinical Trial

Inclusion Criteria

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

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Yunseok Jeon, MD, PhD, Principal Investigator, Seoul National University Hospital

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