Prediction of Thrombosis Using D-dimer Trends in COVID-19

Study Overview
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Brief Summary
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A high incidence of venous thromboembolic events (VTE) has been demonstrated in COVID-19. This incidence correlates with disease severity. Activation of coagulation secondary to sepsis combined with classical thrombotic risk factors may contribute to this prothrombotic state. Since the beginning of March 2020, the issue of venous thrombosis during SARS-CoV-2 infection has rapidly emerged as a major medical challenge since a significant rate of patients were thrombosing, some of them in spite of a well conducted preventive anticoagulation. Although D-dimers have been shown to be useful in identifying patients at risk of severe COVID-19 and even mortality, they cannot be used for diagnostic exclusion of pulmonary embolism. Indeed, since D-dimer levels rise non-specifically during infectious states, the exclusion threshold of 500 ng/ml cannot be used. It would therefore be useful to study the predictive value of D-dimers for thrombosis in COVID-19 patients.

Detailed Description
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Primary outcome : Characterize different D-dimer trends in COVID-19 patients. Secondary outcomes : Identify the predictive value of different D-dimers trends for thrombosis / all-cause mortality / orotracheal intubation during hospitalization Identify the predictive value of D-dimers at admission for thrombosis / all-cause mortality / orotracheal intubation during hospitalization Identify the predictive value of 1st D-dimer/fibrinogen ratio for thrombosis / all-cause mortality / orotracheal intubation during hospitalization

Official Title
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Predictive Value of D-dimers Trends and Levels for Thrombosis in Patients With COVID-19

Conditions
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Covid19

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Positive SARS-CoV-2 PCR and at least one D-dimer result Non inclusion Criteria: Below 18 yo

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 |
| --- | --- |
| COVID-19<br>Patients with COVID-19 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| D-dimer trends | Modifications of D-dimers overtime during the hospitalization | From date of admission until the date of first documented thrombosis or date of death from any cause, or date of intubation whichever came first, assessed up to 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thrombosis | Arterial or venous thrombosis | From date of admission until the date of first documented thrombosis or date of death from any cause, or date of intubation whichever came first, assessed up to 1 month | 
| All-cause mortality | All-cause mortality | From date of admission until the date of first documented thrombosis or date of death from any cause, or date of intubation whichever came first, assessed up to 1 month | 
| Orotracheal intubation | Orotracheal intubation | From date of admission until the date of first documented thrombosis or date of death from any cause, or date of intubation whichever came first, assessed up to 1 month |