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NCT Number: NCT04366778

Thrombosis and Covid-19

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.

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Key information

Conditions

Thrombosis COVID-19 Cardiovascular Diseases Coronaviridae Infections Coronavirus Infections Embolism and Thrombosis Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections SARS-CoV 2 Vascular Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Louis Pradel

Bron, 69500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TEM-tPA

Diagnostic Test

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.

Primary outcomes

  1. Coagulability

    Time frame: Day 0

    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)

  2. Coagulability

    Time frame: Day 3

    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)

  3. Coagulability

    Time frame: Day 6

    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)

  4. Coagulability

    Time frame: Day 9

    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)

  5. Coagulability

    Time frame: Day 12

    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)

  6. Coagulability

    Time frame: 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)

  7. Venous thrombotic event (VTE) or arterial thrombosis

    Time frame: Day 15

    Occurence of VTE or arterial thrombosis during hospitalization :

    • Pulmonary embolism diagnosed with CT scan
    • Venous or arterial thrombosis diagnosed with ultrasound exam

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: COVBIO

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 29, 2020
Registry last updated
Jan 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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