Clinical Trials Directory

Trials / Completed

CompletedNCT04827160

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

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

Status
Completed
Phase
Study type
Observational
Enrollment
280 (actual)
Sponsor
Central Hospital, Nancy, France · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Detailed description

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

Conditions

Timeline

Start date
2020-03-02
Primary completion
2020-08-11
Completion
2020-08-11
First posted
2021-04-01
Last updated
2021-04-01

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04827160. Inclusion in this directory is not an endorsement.