Clinical trial NCT04359212: Increased Risk of VTE and Higher Hypercoagulability in Patients Recovered in ICU and in Medical Ward for COVID-19
Official title: Increased Risk of Venous Thromboembolism and Higher Hypercoagulable State in Patients Recovered in Intensive Care Unit and in Medical Ward for Coronavirus Disease 2019 (COVID-19)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Disease
Thromboembolism, Venous
Keywords: COVID-19 pandemic
Thromboembolism, Venous
Deep Venous Thrombosis
Pulmonary Thrombosis
Lead sponsor: Quovadis Associazione
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliera di Padova
First posted: 2020-04-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients aged \> 18 years with a confirmed infection for COVID-19 and needing admission to a medical division for a non-severe clinical disease (Group 1) or to the ICU for a severe to critical disease (Group 2) will be eligible for the study.

Brief summary: The aim of this study is to verify if patients admitted to hospital in a medical division and in the intensive care unit for a COVID-19 infection are at higher risk of developing a VTE complication and if they actually present an increased hypercoagulable state.

Detailed description: Between December 2019 and January 2020, a new type of coronavirus, named as "coronavirus disease 2019 - COVID-19" by the World Health Organization, has widely spread throughout the world, becoming a global health threat. The new COVID-19 is similar to other two types of coronavirus that in the past two decades have emerged as cause of severe human disease: Severe Acute Respiratory Syndrome CoV (SARS-CoV) and Middle East Respiratory Syndrome CoV (MERS-CoV). Severe respiratory disease or respiratory failure are the principal symptoms of critical patients, needing a management in ICU with mechanical ventilation.18 Data coming from laboratory results show a leucopenia mainly represented by a lymphopenia, that is a cardinal feature of COVID-19. Moreover, the concentration of several serum pro-thrombotic cytokines, such as interleukins (mainly IL-6, increased in 52% of patients), TNF-α, D-Dimer are reported to be significantly higher in COVID-19 patients, and significantly higher in ICU-patients than in non-ICU patients, suggesting an increased hypercoagulable state that, joined to the other main risk factors (immobilization, ICU admission, mechanical ventilation, infective disease), place these patients to a potential greater risk of developing VTE complications.

Eligibility criteria: Inclusion Criteria:

* aged \>= 18 years
* needing admission to a medical hospital division or to an ICU
* with a confirmed infection for COVID-19

Exclusion Criteria:

* aged \< 18 years

Primary outcomes:
measure: the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism
timeFrame: 28 days
Secondary outcomes:
measure: the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism plus the asymptomatic incidentally detected pulmonary embolism
timeFrame: 28 days
Other outcomes:
Locations:
city: Padova
country: Italy
facility: Giuseppe Camporese
Study officials:
affiliation: Department of Medicine, University of Padua (I)
name: Paolo Simioni, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.
citation: Flumignan RL, Tinoco JDS, Pascoal PI, Areias LL, Cossi MS, Fernandes MI, Costa IK, Souza L, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Prophylactic anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD013739. doi: 10.1002/14651858.CD013739.