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

NCT ID: NCT04359212

Last Updated: 2020-09-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 90 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-01
• Study Completion Date: 2020-07-31

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.

Conditions

COVID-19 Disease; Thromboembolism, Venous

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Medical

subject with a confirmed infection for COVID-19 and needing admission to a medical division for a non-severe clinical disease

thromboprophylaxis with low-molecular-weight heparin or fondaparinux

Intervention Type: DRUG

thromboprophylaxis with low-molecular-weight heparin or fondaparinux

Intensive

subject with a confirmed infection for COVID-19 and needing admission to an Intensive Cure Unit for a severe to critical disease

thromboprophylaxis with low-molecular-weight heparin or fondaparinux

Intervention Type: DRUG

thromboprophylaxis with low-molecular-weight heparin or fondaparinux

Interventions

thromboprophylaxis with low-molecular-weight heparin or fondaparinux

thromboprophylaxis with low-molecular-weight heparin or fondaparinux

Intervention Type: DRUG

Other Intervention Names

thromboprophylaxis

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera di Padova

OTHER

Sponsor Role: collaborator

Quovadis Associazione

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paolo Simioni, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine, University of Padua (I)

Locations

Giuseppe Camporese

Padua, , Italy

Countries

Italy

References

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.

Reference Type: DERIVED

PMID: 35244208 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33502773 (View on PubMed)

Other Identifiers

VTE-COVID

Identifier Type: -

Identifier Source: org_study_id