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临床试验/NCT03203148
NCT03203148已完成不适用

Comparison of Two Point of Care Techniques Mechanical Versus Biochemical Activated Clotting Time

Umeå University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年4月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Activated Clotting time

研究概览

简要总结

In this observational study a comparison is made between two different monitors for measurement of the activated clotting time (ACT): mechanical versus biochemical techniques

详细描述

The ACT is a functional test influenced by multiple factors, such as platelet function, coagulation factors, temperature and contact activation inhibitors. Results produced by different monitors are also prone to vary influenced by the specific method employed to perform the test.

The present clinical study aims to compare two types of ACT monitors: the Hemostatic Management System Plus (Medtronic) and i-STAT (Abbott) in 20 cardiac surgical patients by performing five intraoperative consecutive measurements using anti factor Xa as a reference for the actual heparin concentration.

Inclusion criteria comprised patients aged 20-80 years, scheduled for coronary bypass surgery.

Measurements: 1) before induction of anaesthesia 2 ) after heparin bolus 3) rewarming of the patient 4) weaning from cardiopulmonary bypass 5) after protamine administration.

The Hemostatic System Plus ACT monitor served as reference for dosing of heparin in all patients. The study protocol did not intervene with the standard protocol used for anticoagulation. No patient interventions were made.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • Patients listed for coronary bypass surgery, -

排除标准

  • Primary coagulation disorder, diabetes mellitus, ongoing anti-coagulation therapy, emergency, reduced kidney function, allergy for fish, sea food and protamine

结局指标

主要结局

Activated Clotting time

时间窗: Intraoperative

Coagulation Measure

次要结局

  • Anti-Factor Xa(Intraoperative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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