Thrombosis and Covid-19 (COVBIO)

Civil Hospices of Lyon

Status: Completed

Conditions: SARS-CoV 2; Thrombosis; Covid-19

Treatments: Diagnostic Test: TEM-tPA

Study type: Observational

Funder types: Other

Identifiers

NCT04366778

69HCL20_0401 - COVBIO

ID-RCB (Other Identifier)

Details and patient eligibility

About

The coronavirus disease of 2019 (COVID-19) is a viral illness caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV2), now deemed a pandemic by the World Health Organization. Some COVID-19 patients may develop coagulopathy which is associated with poor prognosis and high risk of thrombosis. Some patients develop severe thrombotic complications, such as pulmonary embolism, despite anti-thrombotic prophylaxis by low molecular weight heparin. The aim of this project is to evaluate modified thromboelastometry for identifying patients at high risk of thrombosis. The hypothesize is that hypofibrinolysis with increased plasma PAI-1, TAFI (thrombin-activatable fibrinolysis inhibitor ) levels in association with high thrombin generation may explain high incidence of thrombosis in this population. A simple laboratory assay, widely available in hospitals, such as thromboelastometry, might be of great clinical interest to detect Covid-19 patients with high risk of thrombosis. In order to make ROTEM more sensitive to hypofibrinolysis, exogenous t-PA will be added in the assay. The preliminary results showed that patients with Covid-19 have significant hypercoagulability detectable with ROTEM and Covid-19 patients with thrombosis have both hypercoagulability and hypofibrinolysis.

Enrollment: 341 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with Covid-19
• non-opposition of the patient to participate

Exclusion criteria

• Non-Covid-19 acute respiratory distress syndrome
• Non-Covid septicemia
• Pregnant women
• Breastfeeding women
• Protected vulnerable adults

Trial design

341 participants in 2 patient groups

patients hospitalized for Covid-19

Description:

Patients with Covid-19 infection hospitalized in Lyon University Hospitals

Treatment:

Diagnostic Test: TEM-tPA

patients hospitalized for Covid-19 who present thrombosis

Description:

Patients with Covid-19 infection hospitalized in Lyon University Hospitals who present thrombosis during hospitalization

Treatment:

Diagnostic Test: TEM-tPA