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| Name | Class |
|---|---|
| Hospital Ambroise Paré Paris | OTHER |
| University Hospital, Brest | OTHER |
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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.
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.
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.
The main objective of this work is therefore to determine the incidence of the occurrence of PE in patients with hospitalized SARS-CoV-2 pneumonitis by performing systematic thoracic angiography scanner in all hospitalized patients.
The secondary objective is to study the coagulation and fibrinolysis profile in these patients and to assess endothelial activation in order to better understand the physio-pathological mechanism behind PE and to determine if one of the parameters studied could be an indicator of PE risk.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hospitalized SARS Cov-2 | Experimental | Hospitalized patients diagnosed with SARS Cov-2 infection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Angiography scanner | Radiation | systematic thoracic angiography scanner to diagnose pulmonary embolism and additional blood sample (hemostasis exploration) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Rate of patients with pulmonary embolism | Rate of patients with pulmonary embolism diagnosed by thoracic angiography scanner | up to Day 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Prothrombin level measurement | Measure of prothrombin level to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization | up to Day 12 |
| activated partial thromboplastin time measurement |
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Inclusion Criteria:
≥ 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
signed informed consent before any study procedure
patients affiliated to an appropriate health insurance system
Exclusion Criteria:
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:
Patient with contra-indication to contrast media (Iomeron350®, Visipaque®):
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).
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| Name | Affiliation | Role |
|---|---|---|
| Colas TCHERAKIAN, MD | Foch HOSPITAL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HĂ´pital Foch | Suresnes | 92150 | France |
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| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011655 | Pulmonary Embolism |
| D012128 | Respiratory Distress Syndrome |
| D020141 | Hemostatic Disorders |
| ID | Term |
|---|---|
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
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Determination of incidence of occurrence of pulmonary embolism in hospitalized patients with SARS-CoV-2 pneumonitis, first by performing systematic thoracic angiography scanner in all hospitalized patients and then to explore hemostasis profile
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Measure of activated partial thromboplastin time to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization
| up to Day 12 |
| Fibrinogen measurement | Measure of fibrinogen to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization | up to Day 12 |
| D-dimers measurement | Measure of D-dimers to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization | up to Day 12 |
| Protein C measurement | Measure of Protein C to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization | up to Day 12 |
| Willebrand antigen measurement | Measure of Willebrand antigen to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization | up to Day 12 |
| Soluble tissue factor measurement | Measure of Soluble tissue factor to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization | up to Day 12 |
| Soluble thrombomodulin measurement | Measure of soluble thrombomodulin to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization | up to Day 12 |
| E-selectin measurement | Measure of E-selectin to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization | up to Day 12 |
| Thrombin-antithrombin complex measurement | Measure of thrombin-antithrombin complex to assess hemostasis parameters of patients with SARS-COV-2pneumonitis during hospitalization | up to Day 12 |
| Assessment of clot formation curve | Assessment of clot formation curve by Thrombodynamics® to identify ones predictive of the onset of Pulmonary Embolism or a poor prognosis | Day 1 |
| Assessment of thrombin generation | Assessment of thrombin generation by Thrombodynamics® to identify ones predictive of the onset of Pulmonary Embolism or a poor prognosis | Day 1 |
| Assessment of fibrinolysis | Assessment of fibrinolysis by Thrombodynamics® to identify ones predictive of the onset of Pulmonary Embolism or a poor prognosis | Day 1 |
| Mortality | Determine patient mortality | Day 30 |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004617 | Embolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012120 | Respiration Disorders |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |