Thrombosis and Covid-19

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of TEM-tPA (Thromboelastometry With tPA) to Detect Covid-19 Patients at High Risk of Thrombosis

Conditions
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Thrombosis, Covid-19, SARS-CoV 2

Intervention / Treatment
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* Diagnostic Test: TEM-tPA


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients hospitalized for Covid-19<br>Patients with Covid-19 infection hospitalized in Lyon University Hospitals | Diagnostic Test: TEM-tPA<br>* 325 patients with Covid-19 hospitalized in Lyon University Hospitals will have TEM-tPA measurements in parallel to D-dimers every 3 days during the hospitalization period. TEM-tPA of patients with and without thrombosis will be compared and their fibrinolysis (PAI-1, TAFI, tPA, thrombin) will be further explored.<br>|
| patients hospitalized for Covid-19 who present thrombosis<br>Patients with Covid-19 infection hospitalized in Lyon University Hospitals who present thrombosis during hospitalization | Diagnostic Test: TEM-tPA<br>* 325 patients with Covid-19 hospitalized in Lyon University Hospitals will have TEM-tPA measurements in parallel to D-dimers every 3 days during the hospitalization period. TEM-tPA of patients with and without thrombosis will be compared and their fibrinolysis (PAI-1, TAFI, tPA, thrombin) will be further explored.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coagulability | TEM-tPA profile of patients will be defined with a combination of the following parameters : Maximal Clot Firmness (MCF) (mm) alpha angle (°) Lysis Index (LI) 30 (%) Lysis Onset Time (LOT) (min) | Day 0 | 
| Coagulability | TEM-tPA profile of patients will be defined with a combination of the following parameters : Maximal Clot Firmness (MCF) (mm) alpha angle (°) Lysis Index (LI) 30 (%) Lysis Onset Time (LOT) (min) | Day 3 | 
| Coagulability | TEM-tPA profile of patients will be defined with a combination of the following parameters : Maximal Clot Firmness (MCF) (mm) alpha angle (°) Lysis Index (LI) 30 (%) Lysis Onset Time (LOT) (min) | Day 6 | 
| Coagulability | TEM-tPA profile of patients will be defined with a combination of the following parameters : Maximal Clot Firmness (MCF) (mm) alpha angle (°) Lysis Index (LI) 30 (%) Lysis Onset Time (LOT) (min) | Day 9 | 
| Coagulability | TEM-tPA profile of patients will be defined with a combination of the following parameters : Maximal Clot Firmness (MCF) (mm) alpha angle (°) Lysis Index (LI) 30 (%) Lysis Onset Time (LOT) (min) | Day 12 | 
| Coagulability | TEM-tPA profile of patients will be defined with a combination of the following parameters : Maximal Clot Firmness (MCF) (mm) alpha angle (°) Lysis Index (LI) 30 (%) Lysis Onset Time (LOT) (min) | Day 15 | 
| Venous thrombotic event (VTE) or arterial thrombosis | Occurence of VTE or arterial thrombosis during hospitalization : Pulmonary embolism diagnosed with CT scan Venous or arterial thrombosis diagnosed with ultrasound exam | Day 15 |