NCT05855317招募中不适用
Association Between the Level of Extracellular Vesicle - Associated Tissue Factor and the Occurence of Pulmonary Embolism in Patients With Acute Respiratory Distress Syndrome
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Difference in EV-TF levels at inclusion between patients with and without pulmonary embolism at day 7 postinclusion
研究概览
简要总结
In this study, 120 patients with Acute Respiratory Distress Syndrome (ARDS) will be included on a two years-period in an intensive care unit (Assistance Publique des Hôpitaux de Marseille, France). Those patients will benefit from a blood test at inclusion in order to measure several coagulation biomarkers, including EV-TF. Subsequently, these patients will be treated according to the usual practices of the department, following recommendations. Patients who received an injected CT scan between Day 5 and Day 28 will be divided into two groups based on the presence or absence of a pulmonary embolism on imaging. The measured values of EV-TF levels and other studied biomarkers will be compared between these two groups in order to detect a possible association between them and the diagnosis of pulmonary embolism. It should be noted that patients receiving an injected CT-scan between Day 5 and Day 7 will be included in the main analysis while those receiving it between Day 8 and Day 28 will be included in the secondary analysis. Others will be excluded from any analysis. At the same time, several collections of clinical data will be carried out: on Day 1, Day 7, Day 28, and on the day of the CT scan if it is performed at another time.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient 18 years of age or older,
- •Patient who has given his/her non-opposition to participate in this study, or alternatively, patient for whom a relative has given his/her non-opposition to participate in this study,
- •Patient admitted to intensive care for less than 24 hours,
- •Patient with ARDS according to the Berlin criteria,
- •Hypoxemia with PaO2/FiO2 ratio ≤ 300 on mechanical ventilation under PEEP ≥ 5 cmH2O,
- •Bilateral alveolar-interstitial opacities on chest imaging (chest X-ray or CT),
- •Exclusion of a cardiogenic cause on echocardiography,
- •Acute or subacute onset within 7 days based on the clinical-radiological profile.
排除标准
- •Positive SARS-CoV-2 PCR in a pharyngeal or respiratory sample (cytobacteriological examination of sputum, bronchial aspiration or bronchoalveolar lavage) prior to admission to the intensive care unit,
- •Patient with a pathology affecting the coagulation process or endothelial function (hemophilia, von Willebrand disease, etc.),
- •Patient receiving curative anticoagulant treatment before admission to the intensive care unit,
- •Patient undergoing extracorporeal veno-venous respiratory assistance (ECMO-VV) before admission to the intensive care unit,
- •Patient undergoing extra-renal purification with systemic anticoagulation with heparin before admission to the intensive care unit,
- •Persons referred to in articles L. 1121-5 to L. 1121-8 of the Public Health Code (minor patients, adult patients under tutorship or guardianship, patients deprived of their liberty, pregnant or nursing women),
- •Moribund patients for whom the life expectancy is less than 24 hours according to the opinion of the investigating physician.
研究组 & 干预措施
Patients with pulmonary embolism
The presence of pulmonary embolism is determined from a CT scan realized between Day 5 and Day 28.
干预措施: Blood sample (Other)
Patients without pulmonary embolism
The absence of pulmonary embolism is determined from a CT scan realized between Day 5 and Day 28.
干预措施: Blood sample (Other)
结局指标
主要结局
Difference in EV-TF levels at inclusion between patients with and without pulmonary embolism at day 7 postinclusion
时间窗: Day 7
EV-TF level is determined from a blood sample realized at inclusion and the presence of pulmonary embolism from a CT scan realized during the first week of patient care in intensive care unit.
次要结局
- Difference in EV-TF levels at inclusion between patients with and without pulmonary embolism at day 28 postinclusion(Day 28)
- Association between EV-TF level and alveolar dead space at day 28 postinclusion(Day 28)
- Association between EV-TF level and alveolar dead space at thoracic CT scan day(Between day 5 and day 28)
- Difference in EV-TF levels at inclusion between patients with and without venous thrombo-embolic disease at day 7 postinclusion(Day 7)
- Difference in EV-TF levels at inclusion between patients with and without venous thrombo-embolic disease at day 28 postinclusion(Day 28)
- Association between EV-TF levels and patient prognosis(Day 60)
- Association between EV-TF level and alveolar dead space at inclusion(Day 1)
- Association between EV-TF level and alveolar dead space at day 7 postinclusion(Day 7)
- Optimal threshold value of EV-TF associated with the occurrence of pulmonary embolism.(Day 28)
- Optimal threshold value of EV-TF associated with the occurrence of venous thrombo-embolic disease.(Day 28)
- Optimal threshold value of EV-TF associated with the occurrence of death(Day 60)
- Predictive value of Willebrand antigen at inclusion on the occurrence of pulmonary embolism at day 7.(Day 7)
- Predictive value of ADAMTS13 activity at inclusion on the occurrence of pulmonary embolism at day 7.(Day 7)
- Predictive value of circulating levels of antithrombin (coagulation inhibitor) at inclusion on the occurrence of pulmonary embolism at day 7.(Day 7)
- Predictive value of fibrin monomers (circulating fibrinolytic potential) at inclusion on the occurrence of pulmonary embolism at day 7.(Day 7)
- Predictive value of circulating levels of protein C (coagulation inhibitor) at inclusion on the occurrence of pulmonary embolism at day 28.(Day 28)
- Predictive value of circulating levels of protein S (coagulation inhibitor) at inclusion on the occurrence of pulmonary embolism at day 28.(Day 28)
- Predictive value of circulating levels of protein C (coagulation inhibitor) at inclusion on the occurrence of pulmonary embolism at day 7.(Day 7)
- Predictive value of circulating levels of protein S (coagulation inhibitor) at inclusion on the occurrence of pulmonary embolism at day 7.(Day 7)
- Predictive value of D-dimers (circulating fibrinolytic potential) at inclusion on the occurrence of pulmonary embolism at day 7.(Day 7)
- Predictive value of circulating PAI-1 (circulating fibrinolytic potential) at inclusion on the occurrence of pulmonary embolism at day 7.(Day 7)
- Predictive value of Willebrand antigen at inclusion on the occurrence of pulmonary embolism at day 28.(Day 28)
- Predictive value of ADAMTS13 activity at inclusion on the occurrence of pulmonary embolism at day 28.(Day 28)
- Predictive value of circulating levels of antithrombin (coagulation inhibitor) at inclusion on the occurrence of pulmonary embolism at day 28.(Day 28)
- Predictive value of D-dimers (circulating fibrinolytic potential) at inclusion on the occurrence of pulmonary embolism at day 28.(Day 28)
- Predictive value of circulating PAI-1 (circulating fibrinolytic potential) at inclusion on the occurrence of pulmonary embolism at day 28.(Day 28)
- Predictive value of Willebrand antigen at inclusion on the occurrence of venous thrombo-embolic disease at day 7.(Day 7)
- Predictive value of fibrin monomers (circulating fibrinolytic potential) at inclusion on the occurrence of pulmonary embolism at day 28.(Day 28)
- Predictive value of ADAMTS13 activity at inclusion on the occurrence of venous thrombo-embolic disease at day 7.(Day 7)
- Predictive value of circulating levels of antithrombin (coagulation inhibitor) at inclusion on the occurrence of venous thrombo-embolic disease at day 7.(Day 7)
- Predictive value of circulating levels of protein C (coagulation inhibitor) at inclusion on the occurrence of venous thrombo-embolic disease at day 7.(Day 7)
- Predictive value of circulating levels protein S (coagulation inhibitor) at inclusion on the occurrence of venous thrombo-embolic disease at day 7.(Day 7)
- Predictive value of D-dimers (circulating fibrinolytic potential) at inclusion on the occurrence of venous thrombo-embolic disease at day 7.(Day 7)
- Predictive value of circulating levels of antithrombin (coagulation inhibitor) at inclusion on the occurrence of venous thrombo-embolic disease at day 28.(Day 28)
- Predictive value of circulating levels of protein C (coagulation inhibitor) at inclusion on the occurrence of venous thrombo-embolic disease at day 28.(Day 28)
- Predictive value of fibrin monomers (circulating fibrinolytic potential) at inclusion on the occurrence of venous thrombo-embolic disease at day 7.(Day 7)
- Predictive value of circulating PAI-1 (circulating fibrinolytic potential) at inclusion on the occurrence of venous thrombo-embolic disease at day 7.(Day 7)
- Predictive value of ADAMTS13 activity at inclusion on the occurrence of venous thrombo-embolic disease at day 28.(Day 28)
- Predictive value of Willebrand antigen at inclusion on the occurrence of venous thrombo-embolic disease at day 28.(Day 28)
- Predictive value of circulating levels of protein S (coagulation inhibitor) at inclusion on the occurrence of venous thrombo-embolic disease at day 28.(Day 28)
- Predictive value of D-dimers (circulating fibrinolytic potential) at inclusion on the occurrence of venous thrombo-embolic disease at day 28.(Day 28)
- Predictive value of fibrin monomers (circulating fibrinolytic potential) at inclusion on the occurrence of venous thrombo-embolic disease at day 28.(Day 28)
- Predictive value of circulating PAI-1 (circulating fibrinolytic potential) at inclusion on the occurrence of venous thrombo-embolic disease at day 28.(Day 28)
- Predictive value of Willebrand antigen at inclusion on the patients' death.(Day 60)
- Predictive value of ADAMTS13 activity at inclusion on the patients' death.(Day 60)
- Predictive value of of circulating levels of antithrombin (coagulation inhibitor) at inclusion on the patients' death.(Day 60)
- Predictive value of of circulating levels of protein C (coagulation inhibitor) at inclusion on the patients' death.(Day 60)
- Predictive value of of circulating levels of protein S (coagulation inhibitor) at inclusion on the patients' death.(Day 60)
- Predictive value of D-dimers (circulating fibrinolytic potential) at inclusion on the patients' death.(Day 60)
- Predictive value of fibrin monomers (circulating fibrinolytic potential) at inclusion on the patients' death.(Day 60)
- Predictive value of circulating PAI-1 (circulating fibrinolytic potential) at inclusion on the patients' death.(Day 60)
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
The Mechanism of Extracellular Vesicles Containing Mitochondrial DNA in ARDS Lung Injury Caused by Extrapulmonary SepsisARDS, HumanNCT05061212Southeast University, China50
Unknown
不适用
Clinical Studies of the Effects of Extracorporeal Membrane Oxygenation for Severe ARDS MortalityECMO TreatmentNCT01677117Southeast University, China25
已完成
不适用
Extra Vascular Lung Water and Pulmonary Permeability in Critically Ill Patients With SARS-CoV-2 (COVID-19)COVID-19PneumoniaAcute Respiratory Distress SyndromeNCT04376905University Hospital, Montpellier30
招募中
不适用
Alveolar and Serum sRAGE in Severe Asthma in ChildrenAsthma in ChildrenNCT05364996University Hospital, Clermont-Ferrand85
Unknown
不适用
Explore Potential Plasma and BALF Immunometabolic and Lipidomic Biomarkers for Identifying ARDS EndotypesAcute Respiratory Distress SyndromeAcute Respiratory FailureNCT05451342Peking Union Medical College Hospital200