Coagulopathy in COVID19 - A Multi-Centre Observational Study in UK (COVID19)
2020年7月30日 更新者:Imperial College London
Coagulopathy Associated With Coronavirus disease19 (CA-COVID19) A Multi-Centre Observational Study in UK
A novel Coronavirus (COVID-19) infection leading to pneumonia and severe acute respiratory failure [acute respiratory distress syndrome (ARDS)] and death is a global threat.
On 11/03/2020, WHO declared the Covid-19 outbreak a global pandemic.
As of 18th of March, there are 202,309 confirmed cases with 8,013 deaths.
Patients with severe illness may develop dyspnoea and hypoxemia within 1week after onset, which may quickly progress to ARDS or end-organ failure 1.
Based on Chinese data abnormal coagulation parameters (Prolonged Prothrombin time [PT] and raised D dimer) are reported to predict a poor prognosis and may therefore be important therapeutic targets.
The number of patients with infected with COVID- 19 in UK is rapidly rising as with many other European countries.
Eventually >50% of people will have become infected and COVID-19 will remain a public health threat in the long term.
It is therefore very important to understand every aspect of this disease, including the associated coagulopathy leading bleeding, blood clots (thrombosis) and death.
Emerging data from Europe and some centres in UK, indicates that venous thromboembolism (VTE), mainly pulmonary embolism (PE), is major problem in COVID patients.
In this retrospective-prospective: multicentre study, investigators will document the patient characteristics, presenting haematological parameters and associated comorbidities and their association with bleeding, thrombosis and mortality in patients admitted for hospital treatment.
Determining the predictive value of patient characteristics and presenting laboratory measurements for clinical outcomes in these patients will allow us to optimise management of these patients in the future.
Furthermore, by comparing these data with data from patients without Covid-19, investigators will be able to modify existing protocols and tailor them to the management of COVID -19.
研究概览
研究类型
观察性的
注册 (预期的)
5000
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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London、英国
- 招聘中
- Imperial College Healthcare NHS Trust
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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
不适用
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Adult patients (>18 years) admitted hospitals with suspected COVID-19 infection
描述
Inclusion Criteria:
- Adult patients (>18 years) admitted hospitals with COVID 19 infection (COVID RNA+ +/- radiological change +/- clinical suspicion in absence of RNA)
Exclusion Criteria:
- No exclusions
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
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
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Prevalence and characteristics of coagulation abnormalities and their predictive value for respiratory failure requiring ventilation, multiorgan failure and death in patients presenting with COVID 19 infection
大体时间:12 months
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12 months
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次要结果测量
结果测量 |
大体时间 |
---|---|
Incidence of respiratory failure requiring CPAP or mechanical ventilation
大体时间:12 months
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12 months
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Incidence of thrombosis (clinical or radiological diagnosis) including thrombosis within 90 days after hospital admission (hospital associated thrombosis) 4. Incidence of minor bleeding 5. Heparin induced thrombocytopenia 6. Acute coronary syndrome
大体时间:12 months
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12 months
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Incidence of major bleeding 8. Multiorgan failure 9. Development of DIC 10. Duration of hospital stay (days) 11. Hospital mortality
大体时间:12 months
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12 months
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Incidence of clinically relevant non-major bleeding
大体时间:12 months
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12 months
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Incidence of Heparin induced thrombocytopenia
大体时间:12 months
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12 months
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Incidence of Acute coronary syndrome
大体时间:12 months
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12 months
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Incidence of renal failure requiring renal replacement therapy
大体时间:12 months
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12 months
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Incidence of Multiorgan failure
大体时间:12 months
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12 months
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Incidence of Development of DIC
大体时间:12 months
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12 months
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Duration of hospital stay (days)
大体时间:12 months
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12 months
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Hospital mortality
大体时间:12 months
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12 months
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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。
调查人员
- 学习椅:Dr Deepa Jayakody Arachchillage, FRCPath, MD、Imperial College London
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5月25日
初级完成 (预期的)
2021年4月25日
研究完成 (预期的)
2021年6月25日
研究注册日期
首次提交
2020年5月26日
首先提交符合 QC 标准的
2020年5月26日
首次发布 (实际的)
2020年5月28日
研究记录更新
最后更新发布 (实际的)
2020年7月31日
上次提交的符合 QC 标准的更新
2020年7月30日
最后验证
2020年7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.
Non-interventional的临床试验
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Sheffield Hallam UniversitySheffield Teaching Hospitals NHS Foundation Trust完全的
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Charite University, Berlin, Germany招聘中