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

NCT04479540 | Completed DMC

• 1 other identifier: 2020_0058
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia, Viral

Keywords

SARS COV-2; pulmonary embolism; acute respiratory distress syndrome; coagulation disorders; venous thromboembolic disease

Outcome Measures

Primary Outcomes (1)

• Rate of patients with pulmonary embolism

  Rate of patients with pulmonary embolism diagnosed by thoracic angiography scanner

  up to Day 12

Secondary Outcomes (14)

• Prothrombin level measurement

  up to Day 12

• activated partial thromboplastin time 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

Study Arms (1)

Hospitalized SARS Cov-2

EXPERIMENTAL

Hospitalized patients diagnosed with SARS Cov-2 infection

Radiation: Angiography scanner

Interventions

Angiography scanner RADIATION

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

Hospitalized SARS Cov-2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hopital Foch: lead
• Hospital Ambroise Paré Paris: collaborator
• University Hospital, Brest: collaborator

Study Sites (1)

Hôpital Foch

Suresnes, 92150, France

Location

MeSH Terms

Conditions

Pneumonia, Viral; Pulmonary Embolism; Respiratory Distress Syndrome; Hemostatic Disorders

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Respiration Disorders; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Colas TCHERAKIAN, MD

  Foch HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 21, 2020
• Study Start: May 26, 2020
• Primary Completion: February 26, 2022
• Study Completion: March 5, 2022
• Last Updated: August 3, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)