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

NCT ID: NCT04827160

Last Updated: 2021-04-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 280 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-02
• Study Completion Date: 2020-08-11

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

Conditions

Covid19

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

COVID-19

Patients with COVID-19

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Non inclusion Criteria: Below 18 yo

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Hospital, Nancy, France

OTHER

Sponsor Role: lead

Responsible Party

Stéphane Zuily

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CHRU Nancy

Nancy, , France

Countries

France

Other Identifiers

2020308

Identifier Type: -

Identifier Source: org_study_id