跳至主要内容
临床试验/NCT02209909
NCT02209909已完成不适用

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

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2014年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
change from baseline in platelet p-selectin at 48 hours after operation

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double (Care Provider, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

研究组 & 干预措施

aspirin continuation

Experimental

Intervention : Low-dose aspirin (< 100mg/day) is used before OPCAB surgery in the aspirin continuation group.

干预措施: aspirin continuation (Drug)

aspirin discontinuation

Experimental

Intervention: Low-dose aspirin is stopped more than 4 days before OPCAB surgery in the aspirin discontinuation group.

干预措施: aspirin discontinuation (Drug)

结局指标

主要结局

change from baseline in platelet p-selectin at 48 hours after operation

时间窗: 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.

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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