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临床试验/NCT02979158
NCT02979158已完成不适用

Influence of Cardiopulmonary Bypass on Platelet Function in Patients With Preoperative Dual Antiplatelet Therapy:

Umeå University2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年11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
60
试验地点
2
主要终点
Assessment of platelet function following cardiopulmonary bypass using platelet aggregometry

研究概览

简要总结

Patients admitted for coronary artery bypass surgery taking antiplatelet medicine have an increased risk for bleeding.

Present study aims to compare the platelet function in two patient groups using different types of heart-lung machine methods.

It is assumed that one of the methods is superior verified by sensitive methods of testing platelet function.

详细描述

Taking antiplatelet medication before cardiac surgery increases the risk for bleeding.

The surgical procedure and the use of a heart-lung machine may disturb the function of platelets, why measures to protect the existing function of platelets are of prime concern.

The present study aims to compare how two types of heart-lung machine methods influence platelet function in two groups of patients.

The platelet function will be tested before, during and after surgery by the use of two independent methods.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • Patients accepted for coronary bypass surgery with dual preoperative antiplatelet therapy suspended less than 4 days prior to surgery

排除标准

  • Abnormal coagulation verified from preoperative assessments, platelet count <100 000, Warfarin medication and renal insufficiency (GFR < 60 ml/min)

研究组 & 干预措施

CPB Low Dose

Experimental

Conduct of cardiopulmonary bypass using a low heparin dose verified by the activated clotting time at 250 s

干预措施: CPB Low Dose (Procedure)

CPB High Dose

Experimental

Conduct of cardiopulmonary bypass using a high heparin dose verified by the activated clotting time at 480 s

干预措施: CPB High Dose (Procedure)

结局指标

主要结局

Assessment of platelet function following cardiopulmonary bypass using platelet aggregometry

时间窗: Test of platelet function will be analysed on arrival to the operating room, post cardiopulmonary bypass and on day 1 in the intensive care unit based on the area under the curve depited from the two employed aggremometers

Included aggregometry tests: Multiplate and Rotem Platelet

次要结局

  • Postoperative bleeding(Postoperative bleeding 24 hrs)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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