Skip to main content
OpenTrials
Completed

NCT Number: NCT04827160

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHRU Nancy

Nancy, 54000, France

About this study

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

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Positive SARS-CoV-2 PCR and at least one D-dimer result

Non inclusion Criteria: Below 18 yo

Treatment and study plan

Primary outcomes

  1. D-dimer trends

    Time frame: 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 outcomes

  1. Thrombosis

    Time frame: 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

  2. All-cause mortality

    Time frame: 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

  3. Orotracheal intubation

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: TRENDS

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 1, 2021
Registry last updated
Apr 1, 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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.