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

Completed
Pneumonia, Viral

Radiation: Angiography scanner

systematic thoracic angiography scanner to diagnose pulmonary embolism and additional blood sample (hemostasis exploration)

Eligibility Criteria

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

- Fever

- Cough

- Myalgia

- Asthenia

- Loss of taste/ Anosmia

- 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:

- 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).

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
France
Locations

Hôpital Foch
Suresnes, France

Colas TCHERAKIAN, MD, Principal Investigator
Foch HOSPITAL

NCT Number
Keywords
SARS CoV-2
Pulmonary Embolism
Acute Respiratory Distress Syndrome
coagulation disorders
venous thromboembolic disease
MeSH Terms
Pneumonia, Viral
Lung Diseases
Pulmonary Embolism
Embolism