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

Completed

• Conditions: Covid19

• Registration Number: NCT04827160
• Lead Sponsor: Central Hospital, Nancy, France

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

Study Timeline

• Study Start: 2020-03-02
• Primary Completion: 2020-08-11
• Study Completion: 2020-08-11
• Status Verified: 2021-03
• Study First Submitted: 2021-03-30
• Study First Submitted QC: 2021-03-30
• Last Update Submitted: 2021-03-30
• Study First Posted: 2021-04-01
• Last Update Posted: 2021-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

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

Non inclusion Criteria: Below 18 yo

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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
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

Trial Locations

Locations (1)

CHRU Nancy; 🇫🇷 Nancy, France