TRENDS: Prediction of Thrombosis Using D-dimer Trends in COVID-19
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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Detailed Description
Primary outcome : Characterize different D-dimer trends in COVID-19 patients.
Secondary outcomes :
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Identify the predictive value of different D-dimers trends for thrombosis / all-cause mortality / orotracheal intubation during hospitalization
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Identify the predictive value of D-dimers at admission for thrombosis / all-cause mortality / orotracheal intubation during hospitalization
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Identify the predictive value of 1st D-dimer/fibrinogen ratio for thrombosis / all-cause mortality / orotracheal intubation during hospitalization
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| COVID-19 Patients with COVID-19 |
Outcome Measures
Primary Outcome Measures
- D-dimer trends [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]
Modifications of D-dimers overtime during the hospitalization
Secondary Outcome Measures
- 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]
Arterial or venous thrombosis
- 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]
All-cause mortality
- 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]
Orotracheal intubation
Eligibility Criteria
Criteria
Inclusion Criteria: Positive SARS-CoV-2 PCR and at least one D-dimer result
Non inclusion Criteria: Below 18 yo
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHRU Nancy | Nancy | France | 54000 |
Sponsors and Collaborators
- Central Hospital, Nancy, France
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2020308