NCT04479540

Assessment of the Risk of Pulmonary Embolism and Coagulation Profile in Patients With COVID-19 Lung Disease

Assessment of the Risk of Pulmonary Embolism and Coagulation Profile in Patients With SARS Coronavirus (COV-2) Lung Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 117 (actual)
• Sponsor: Hopital Foch · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Pneumonia, Viral

Interventions

Type	Name	Description
RADIATION	Angiography scanner	systematic thoracic angiography scanner to diagnose pulmonary embolism and additional blood sample (hemostasis exploration)

Timeline

• Start date: 2020-05-26
• Primary completion: 2022-02-26
• Completion: 2022-03-05
• First posted: 2020-07-21
• Last updated: 2022-08-03

Locations

1 site across 1 country: France