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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04827160
Acronym
TRENDS
Enrollment
280
Registered
2021-04-01
Start date
2020-03-02
Completion date
2020-08-11
Last updated
2021-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

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.

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

Interventions

None listed

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
D-dimer trendsFrom 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 monthModifications of D-dimers overtime during the hospitalization

Secondary

MeasureTime frameDescription
ThrombosisFrom 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 monthArterial or venous thrombosis
All-cause mortalityFrom 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 monthAll-cause mortality
Orotracheal intubationFrom 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 monthOrotracheal intubation

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026