Increased Risk of VTE and Higher Hypercoagulability in Patients Recovered in ICU and in Medical Ward for COVID-19 (VTE-COVID)

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)

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.

Study Overview

• Status: Completed
• Conditions: COVID-19 Disease; Thromboembolism, Venous
• Intervention / Treatment: Drug: thromboprophylaxis with low-molecular-weight heparin or fondaparinux

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.

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Italy
  • Padova, Italy, 35138
    • Giuseppe Camporese

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Medical; subject with a confirmed infection for COVID-19 and needing admission to a medical division for a non-severe clinical disease	Drug: thromboprophylaxis with low-molecular-weight heparin or fondaparinux; thromboprophylaxis with low-molecular-weight heparin or fondaparinux; Other Names: thromboprophylaxis
Intensive; subject with a confirmed infection for COVID-19 and needing admission to an Intensive Cure Unit for a severe to critical disease	Drug: thromboprophylaxis with low-molecular-weight heparin or fondaparinux; thromboprophylaxis with low-molecular-weight heparin or fondaparinux; Other Names: thromboprophylaxis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism	the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism plus the asymptomatic incidentally detected pulmonary embolism	the cumulative proportion of any distal or proximal deep venous thrombosis or of symptomatic pulmonary embolism plus the asymptomatic incidentally detected pulmonary embolism	28 days

Collaborators and Investigators

• Sponsor: Quovadis Associazione
• Collaborators: Azienda Ospedaliera di Padova
• Investigators: Principal Investigator: Paolo Simioni, MD, Department of Medicine, University of Padua (I)

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2020
• Primary Completion (ACTUAL): June 30, 2020
• Study Completion (ACTUAL): July 31, 2020

Study Registration Dates

• First Submitted: April 21, 2020
• First Submitted That Met QC Criteria: April 21, 2020
• First Posted (ACTUAL): April 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 17, 2020
• Last Update Submitted That Met QC Criteria: September 15, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: COVID-19 pandemic; Deep Venous Thrombosis; Thromboembolism, Venous; Pulmonary Thrombosis
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Embolism and Thrombosis; COVID-19; Thromboembolism; Venous Thromboembolism; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Fibrinolytic Agents; Fibrin Modulating Agents; Protease Inhibitors; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; Anticoagulants; Heparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin; Fondaparinux; PENTA
• Other Study ID Numbers: VTE-COVID

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No