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临床试验/NCT06912009
NCT06912009招募中不适用

Evaluation of the Duration of Obtaining Curative Anticoagulation in Patients With Clinically Significant Pulmonary Embolism in an Intensive Care Unit

University Hospital, Strasbourg, France1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年11月6日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
100
试验地点
1
主要终点
To determine the time to effective anticoagulation with HNF in the treatment of high-risk and intermediate-risk pulmonary embolism in an intensive care unit.

研究概览

简要总结

Current management of intermediate- and high-risk pulmonary embolism is primarily based on curative subcutaneous or intravenous anticoagulation, with or without systemic fibrinolytic therapy or thrombectomy. Initial treatment with low-molecular-weight heparin (LMWH) or fondaparinux is preferred over unfractionated heparin (UFH) due to their lower risk of serious bleeding and heparin-induced thrombocytopenia (HIT). UFH treatment is reserved for patients at risk of hemodynamic instability, renal failure with a GFR < 30 ml/min, or obesity. Biological monitoring of anticoagulation efficacy can be performed by measuring the activated partial thromboplastin time (aPTT), as recommended by the European Society of Cardiology (ESC), or by measuring the antiXa activity of heparin, which has been shown to be beneficial in numerous studies. It is generally accepted that this anticoagulation should be initiated at a curative dose as early as possible, as this reduces in-hospital mortality and 30-day mortality. However, few studies have examined the impact of the time to achieve effective anticoagulation, and those that have done so have only done so in patients with high-risk pulmonary embolism or have based their anticoagulation monitoring on aPTT and not on antiXa activity.

The proposed study aims to evaluate the time to obtain effective anticoagulation and its impact on mortality, thromboembolic recurrence and the occurrence of serious bleeding in patients with clinically significant pulmonary embolism, hospitalized in an intensive care unit as well as the factors that may influence this time. It will also allow to compare the practices of the studied center in terms of initial anticoagulation dose delivered, the initiation or not of a bolus and methods of monitoring anticoagulation with the literature in order to allow an improvement in patient care.

研究设计

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

入排标准

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

入选标准

  • •Adult patient (≥18 years old)
  • •Hospitalized in the intensive care unit of Hautepierre Hospital (Strasbourg University Hospitals UF 6250) between January 1, 2014, and December 31, 2023
  • •With a diagnosis of pulmonary embolism confirmed by a thoracic CT angiogram, a thoracoabdominopelvic CT scan, or a lung scan
  • •Having received anticoagulation with curative-dose unfractionated heparin

排除标准

  • •Subjects who have expressed objection to the reuse of their data for scientific research purposes. - Patients diagnosed with pulmonary embolism prior to admission to the intensive care unit and for whom we cannot precisely determine the start date of anticoagulation (precision estimated to the nearest hour).
  • •Pulmonary embolism not confirmed by contrast imaging (CT angiography)
  • •Patients who have not received curative anticoagulation (contraindication)
  • •Patients already receiving curative anticoagulation with UFH at the time of diagnosis
  • •Patients with low-risk pulmonary embolism defined by an sPESI score of 0
  • •Subject under court protection, guardianship, or curatorship

结局指标

主要结局

To determine the time to effective anticoagulation with HNF in the treatment of high-risk and intermediate-risk pulmonary embolism in an intensive care unit.

时间窗: Up to 10 years

Mean time to achieve effective anticoagulation, defined as the mean time between the initiation of curative anticoagulation and the first antiXa activity value greater than 0.3 units/ml in the case of antiXa monitoring, or an aPTT ratio \> 2 in the case of aPTT monitoring. In the case of monitoring by both aPTT ratio and antiXa activity, the antiXa activity value will be preferred.

次要结局

未报告次要终点

研究者

发起方
University Hospital, Strasbourg, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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