Clinical trial NCT04827160: Prediction of Thrombosis Using D-dimer Trends in COVID-19
Official title: Predictive Value of D-dimers Trends and Levels for Thrombosis in Patients With COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-04-01
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted at Nancy University Hospital for SARS-CoV-2 infection and with at least one D-dimer result from February 24, 2020 to May 12, 2020.

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

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

Non inclusion Criteria: Below 18 yo

Primary outcomes:
measure: D-dimer trends
timeFrame: 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 outcomes:
measure: Thrombosis
timeFrame: 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
measure: All-cause mortality
timeFrame: 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
measure: Orotracheal intubation
timeFrame: 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
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU Nancy
Study officials:
References: