Thrombosis and Covid-19

Completed

• Conditions: SARS-CoV 2; Thrombosis; Covid-19
• Interventions: Diagnostic Test: TEM-tPA

• Registration Number: NCT04366778
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-23
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-29
• Study Start: 2020-05-01
• Status Verified: 2021-01
• Primary Completion: 2021-01-01
• Study Completion: 2021-01-01
• Last Update Submitted: 2021-01-22
• Last Update Posted: 2021-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 341

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients hospitalized for Covid-19	TEM-tPA	Patients with Covid-19 infection hospitalized in Lyon University Hospitals
patients hospitalized for Covid-19 who present thrombosis	TEM-tPA	Patients with Covid-19 infection hospitalized in Lyon University Hospitals who present thrombosis during hospitalization

Primary Outcome Measures

Name	Time	Method
Coagulability	Day 15	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)
Venous thrombotic event (VTE) or arterial thrombosis	Day 15	Occurence of VTE or arterial thrombosis during hospitalization : * Pulmonary embolism diagnosed with CT scan; * Venous or arterial thrombosis diagnosed with ultrasound exam

Trial Locations

Locations (1)

Hôpital Louis Pradel; 🇫🇷 Bron, France