Assessment of the Risk of Pulmonary Embolism and Coagulation Profile in Patients With SARS Coronavirus (COV-2) Lung Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Hopital Foch
- 入组人数
- 117
- 试验地点
- 2
- 主要终点
- Rate of patients with pulmonary embolism
研究概览
简要总结
The current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic is complicated by pneumonia (15 to 20% of cases) requiring hospitalization with oxygen therapy. Almost 20 to 25% of hospitalized patients require intensive care and resuscitation; half die.
The main cause of death is acute respiratory distress syndrome (ARDS). However, some deaths have been linked to pulmonary embolism (PE).
Recognition of PE is important because there is specific treatment to limit its own mortality. The identification of biological parameters of hemostasis predictive of thromboembolic disease is crucial in these patients.
To evaluate the frequency of PE in the patients having to be hospitalized is to practice of a systematic thoracic angiography scanner in the patients having no contra-indication for its realization, as well as during hospitalization in patients deteriorating without any other obvious cause.
The thromboembolic events and disturbances of the coagulation system described in patients with SARS-CoV-2 pneumonitis suggest that this viral infection is associated with an increase in the activation of coagulation contributing to the occurrence of thrombosis and especially from PE.
详细描述
The current severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic is complicated by pneumonia (15 to 20% of cases) requiring hospitalization with oxygen therapy. Almost 20 to 25% of hospitalized patients require intensive care and resuscitation; half die.
On April 3, 2020, in France, 59,105 confirmed cases have been identified. 6,305 people are hospitalized in intensive care and 4,503 patients died.
The main cause of death is acute respiratory distress syndrome (ARDS). However, some deaths have been linked to pulmonary embolism (PE). Very little data is available in the medical literature regarding PE during this infection.
Recognition of PE is important because there is specific treatment to limit its own mortality. The identification of biological parameters of hemostasis predictive of thromboembolic disease is crucial in these patients who are difficult to mobilize.
The diagnostic difficulties with traditional means, the seriousness and the ignorance of a PE make it necessary to evaluate the frequency of it in the patients having to be hospitalized by the practice of a systematic thoracic angiography scanner in the patients having no contra-indication for its realization, as well as during hospitalization in patients deteriorating without any other obvious cause.
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
- 否
入选标准
- •≥ 18 years
- •Any patient who consults in the emergency room, COVID+ with hospitalization criteria (dyspnea or desaturation ≤ 95% or chest pain or hemoptysis), including those who have already performed a CT angiogram upon arrival at the hospital.
- •Positive polymerase chain reaction (PCR) of coronavirus disease or compatible clinical signs associated with suggestive radiological criteria
- •Loss of taste/ Anosmia
- •signed informed consent before any study procedure
- •patients affiliated to an appropriate health insurance system
排除标准
- •Pregnancy in progress
- •Patient not having a microbiological diagnosis of SARS Coronavirus (COV-2) infection or whose symptoms are not suggestive
- •< 18 years
- •Be deprived of liberty or under guardianship
- •Patient with contra-indication to thoracic angiography scanner:
- •State of shock
- •Creatinine clearance < 30 mL/mn in Chronic Kidney Disease (CKD)
- •history of anaphylactic shock or angioedema with iodinated contrast media
- •uncontrolled cardiac decompensation
- •Patient with contra-indication to contrast media (Iomeron350®, Visipaque®):
- •History of immediate major or delayed skin reaction to the injection of a contrast medium
- •Hypersensitivity to the active substance or to any of the excipients
- •overt thyrotoxicosis
- •Patients with renal insufficiency and / or patients with allergy to iodinated contrast products may be included if they can perform a scintigraphy (the pulmonary scintigraphy being the alternative diagnostic to the CT angiography for renal insufficiency and / or allergy to iodinated contrast products).
结局指标
主要结局
Rate of patients with pulmonary embolism
时间窗: up to Day 12
Rate of patients with pulmonary embolism diagnosed by thoracic angiography scanner
次要结局
- Soluble tissue factor measurement(up to Day 12)
- Assessment of thrombin generation(Day 1)
- Prothrombin level measurement(up to Day 12)
- Fibrinogen measurement(up to Day 12)
- D-dimers measurement(up to Day 12)
- Protein C measurement(up to Day 12)
- E-selectin measurement(up to Day 12)
- Thrombin-antithrombin complex measurement(up to Day 12)
- activated partial thromboplastin time measurement(up to Day 12)
- Soluble thrombomodulin measurement(up to Day 12)
- Mortality(Day 30)
- Willebrand antigen measurement(up to Day 12)
- Assessment of clot formation curve(Day 1)
- Assessment of fibrinolysis(Day 1)