跳至主要内容
临床试验/NCT05259241
NCT05259241Unknown不适用

Correlation Between ACT anD APTT During Transcatheter Aortic Valve Implantation and Chronic Total Occlusion Percutaneous Coronary Interventions

Erasmus Medical Center2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年10月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
200
试验地点
2
主要终点
The correlation between the APTT point-of-care test with the coagulation status(Anti-Xa-measurement).

研究概览

简要总结

Rationale: The choice of antithrombotic regimen during TAVI and CTO PCI includes the use of unfractionated heparin. The accuracy of ACT in this setting is disputed. ACT has never been compared to a point-of-care aPTT test for monitoring anticoagulation during percutaneous cardiac interventions.

Objective: The aim of the present study is to evaluate which point-of-care test (ACT or aPTT) gives the best correlation with the coagulation status in patients, defined with the anti-Xa measurement.

Study design: A Single-center, prospective, observational study Study population: patients undergoing TAVI (Cohort A) or CTO PCI (Cohort B) in the Erasmus University Medical Center

Main study parameters/endpoints: The main study endpoints are the correlation between the ACT and APTT point-of-care- tests and the coagulation status, defined as the laboratory anti-Xa measurement.

详细描述

The choice of antithrombotic regimen during TAVI and CTO PCI includes the use of unfractionated heparin. Heparin is the preferred anticoagulant drug in these percutaneous cardiac interventions aiming for an Activated Clotting Time (ACT) > 200sec or 250seconds depending on the procedure. Heparin has a short half-life time and can be neutralized by protamine.

Monitoring the use of unfractionated heparin during TAVI and PCI can be performed with several measurements, like the ACT and aPTT. To measure ACT, an activator is mixed with whole blood to provide a timing of haemostasis. aPTT is a plasma test in which a surface activator is used to measure the time it takes to form a fibrin clot. In nearly every center ACT is the preferred method because of its ease of use and the assumed reliability. ACT-guided heparin regime during TAVI seems effective in minimizing major bleeding events.

There are limited studies focussing on the difference between ACT- and aPTT measurements. The studies which investigated this difference are merely done in patients with continuous heparin infusions, for example in the setting of extracorporeal membrane oxygenation(ECMO). These studies suggest that there is a better correlation between aPTT and dosage heparin than between ACT and heparin. Also, the correlation between ACT and aPTT seems poor.

The accuracy and correlation of ACT with a point-of-care aPTT test for monitoring the anticoagulation effect of unfractionated heparin has so far not been done in the setting of percutaneous interventions. TAVI requires large bore arterial access and is associated with a relevant frequency of access site related bleeding and vascular complications. CTO procedures often require dual arterial access and the use of different strategies with multiple wires which increases the prevalence of vascular complications, including pericardial effusion.

Precise knowledge of actual anticoagulation status during an invasive procedure and at the time of access site closure may affect the incidence of TAVI and CTO PCI related bleeding complications.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • All patients undergoing a TAVI-procedure
  • All patients undergoing a CTO PCI procedure

排除标准

  • 未提供

结局指标

主要结局

The correlation between the APTT point-of-care test with the coagulation status(Anti-Xa-measurement).

时间窗: 30 minutes after heparin bolus

The anti-Xa-measurement(in IU/mL) is defined as the reference for the coagulation status. In this study, we measure the point-of-care APTT measurement(in milliseconds) and the anti-Xa measurement 30 minutes after the heparin bolus to determine the correlation.

The correlation between the ACT point-of-care test with the Anti-Xa-activity measurement).

时间窗: 30 minutes after heparin bolus

The anti-Xa-measurement(in IU/mL) is defined as the reference for the coagulation status. In this study, we measure the point-of-care ACT measurement(in milliseconds) and the anti-Xa measurement 30 minutes after the heparin bolus to determine the correlation.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nicolas van Mieghem

Clinical director of Interventional cardiology

Erasmus Medical Center

研究点 (2)

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