Prevalence and Risk Factors for Venous Thromboembolic Events in Critically Ill Patients With COVID-19
2020年9月25日 更新者:Chiesa Alessandro Felice
Prevalence and Risk Factors for Venous Thromboembolic Events in Critically Ill Patients With SARS-CoV-2 Infection
The purpose of the study is to assess the frequency of the occurrence of a venous thrombosis in patients with the new Coronavirus disease, who are admitted to the Intensive Care Unit for impending respiratory failure requiring intubation and mechanical ventilation.
Furthermore, the investigators aim at identifying potential risk factors for thrombosis and death.
研究概览
详细说明
Symptomatic infection with the severe acute respiratory syndrome coronavirus 2 ranges from mild to critical spectrum.
About 80% of laboratory confirmed infections presented with mild symptoms, usually not requiring hospitalization.
Critical disease requiring respiratory and/or circulatory support was reported in 5% of the subjects.
Acute respiratory distress syndrome represents the most common complication in patients with severe disease.
Several cases of venous thromboembolism in patients with laboratory confirmed infection have been reported, but it is unclear if this occurrence is higher in this specific patients' population.
The purpose of the present study is to assess the prevalence of deep venous thrombosis in patients infected with SARS-CoV-2 admitted to the Intensive care Unit requiring invasive mechanical ventilation using vein ultrasonography.
研究类型
观察性的
注册 (实际的)
80
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
-
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Ticino
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Bellinzona、Ticino、瑞士、6500
- Ospedale Regionale di Bellinzona e Valli
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
All consecutive adult patients with laboratory confirmed SARS-CoV-2 infection admitted to the Intensive Care Unit requiring invasive respiratory support
描述
Inclusion Criteria:
- patients admitted to the Intensive Care Unit
- laboratory confirmed SARS-CoV-2 infection
- invasive respiratory support
Exclusion Criteria:
- none
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Period prevalence of deep vein thrombosis (DVT)
大体时间:From date of inclusion in the study until the date of development of a DVT, date of death from any cause, or date of discharge from the ICU, whichever came first, assessed up to 3 months
|
Percent (%) of patients with a DVT
|
From date of inclusion in the study until the date of development of a DVT, date of death from any cause, or date of discharge from the ICU, whichever came first, assessed up to 3 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
- Huang C, Wang Y, Li X, Ren L, Zhao J, Hu Y, Zhang L, Fan G, Xu J, Gu X, Cheng Z, Yu T, Xia J, Wei Y, Wu W, Xie X, Yin W, Li H, Liu M, Xiao Y, Gao H, Guo L, Xie J, Wang G, Jiang R, Gao Z, Jin Q, Wang J, Cao B. Clinical features of patients infected with 2019 novel coronavirus in Wuhan, China. Lancet. 2020 Feb 15;395(10223):497-506. doi: 10.1016/S0140-6736(20)30183-5. Epub 2020 Jan 24. Erratum In: Lancet. 2020 Jan 30;:
- Wang D, Hu B, Hu C, Zhu F, Liu X, Zhang J, Wang B, Xiang H, Cheng Z, Xiong Y, Zhao Y, Li Y, Wang X, Peng Z. Clinical Characteristics of 138 Hospitalized Patients With 2019 Novel Coronavirus-Infected Pneumonia in Wuhan, China. JAMA. 2020 Mar 17;323(11):1061-1069. doi: 10.1001/jama.2020.1585. Erratum In: JAMA. 2021 Mar 16;325(11):1113.
- Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24. Erratum In: Lancet Respir Med. 2020 Apr;8(4):e26.
- Grasselli G, Zangrillo A, Zanella A, Antonelli M, Cabrini L, Castelli A, Cereda D, Coluccello A, Foti G, Fumagalli R, Iotti G, Latronico N, Lorini L, Merler S, Natalini G, Piatti A, Ranieri MV, Scandroglio AM, Storti E, Cecconi M, Pesenti A; COVID-19 Lombardy ICU Network. Baseline Characteristics and Outcomes of 1591 Patients Infected With SARS-CoV-2 Admitted to ICUs of the Lombardy Region, Italy. JAMA. 2020 Apr 28;323(16):1574-1581. doi: 10.1001/jama.2020.5394. Erratum In: JAMA. 2021 May 25;325(20):2120.
- Wang T, Chen R, Liu C, Liang W, Guan W, Tang R, Tang C, Zhang N, Zhong N, Li S. Attention should be paid to venous thromboembolism prophylaxis in the management of COVID-19. Lancet Haematol. 2020 May;7(5):e362-e363. doi: 10.1016/S2352-3026(20)30109-5. Epub 2020 Apr 9. No abstract available.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年3月3日
初级完成 (实际的)
2020年5月28日
研究完成 (实际的)
2020年5月28日
研究注册日期
首次提交
2020年9月18日
首先提交符合 QC 标准的
2020年9月25日
首次发布 (实际的)
2020年9月29日
研究记录更新
最后更新发布 (实际的)
2020年9月29日
上次提交的符合 QC 标准的更新
2020年9月25日
最后验证
2020年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.