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

Covid19 Clinical Trial

— TRENDS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04827160
• Other study ID #: 2020308
• Status: Completed
• Start date: March 2, 2020
• Est. completion date: August 11, 2020

Study information

• Verified date: March 2021
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: August 11, 2020
• Est. primary completion date: August 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Non inclusion Criteria: Below 18 yo

Related Conditions & MeSH terms

• Covid19
• Thrombosis

Locations

Country	Name	City	State
France	CHRU Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	D-dimer trends	Modifications of D-dimers overtime during the hospitalization	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
Secondary	Thrombosis	Arterial or venous 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
Secondary	All-cause mortality	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
Secondary	Orotracheal intubation	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