Prevalence and Risk Factors for Venous Thromboembolic Events in Critically Ill Patients With COVID-19

NCT ID: NCT04567927

Last Updated: 2020-09-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-03
• Study Completion Date: 2020-05-28

Brief Summary

The purpose of the study is to assess the frequency of the occurrence of a venous thrombosis in patients with the new Coronavirus disease, who are admitted to the Intensive Care Unit for impending respiratory failure requiring intubation and mechanical ventilation. Furthermore, the investigators aim at identifying potential risk factors for thrombosis and death.

Detailed Description

Symptomatic infection with the severe acute respiratory syndrome coronavirus 2 ranges from mild to critical spectrum. About 80% of laboratory confirmed infections presented with mild symptoms, usually not requiring hospitalization. Critical disease requiring respiratory and/or circulatory support was reported in 5% of the subjects. Acute respiratory distress syndrome represents the most common complication in patients with severe disease. Several cases of venous thromboembolism in patients with laboratory confirmed infection have been reported, but it is unclear if this occurrence is higher in this specific patients' population. The purpose of the present study is to assess the prevalence of deep venous thrombosis in patients infected with SARS-CoV-2 admitted to the Intensive care Unit requiring invasive mechanical ventilation using vein ultrasonography.

Conditions

SARS Virus

Study Design

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

Interventions

Ultrasonography

Venous compression ultrasonography using real-time B-mode and colour doppler in transverse and longitudinal views

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• patients admitted to the Intensive Care Unit
• laboratory confirmed SARS-CoV-2 infection
• invasive respiratory support

Exclusion Criteria

• none

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

Sponsors

Chiesa Alessandro Felice

OTHER

Sponsor Role: lead

Responsible Party

Chiesa Alessandro Felice

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Ospedale Regionale di Bellinzona e Valli

Bellinzona, Canton Ticino, Switzerland

Countries

Switzerland

References

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Reference Type: RESULT

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Reference Type: RESULT

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Reference Type: RESULT

PMID: 32091533 (View on PubMed)

Grasselli G, Zangrillo A, Zanella A, Antonelli M, Cabrini L, Castelli A, Cereda D, Coluccello A, Foti G, Fumagalli R, Iotti G, Latronico N, Lorini L, Merler S, Natalini G, Piatti A, Ranieri MV, Scandroglio AM, Storti E, Cecconi M, Pesenti A; COVID-19 Lombardy ICU Network. Baseline Characteristics and Outcomes of 1591 Patients Infected With SARS-CoV-2 Admitted to ICUs of the Lombardy Region, Italy. JAMA. 2020 Apr 28;323(16):1574-1581. doi: 10.1001/jama.2020.5394.

Reference Type: RESULT

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Reference Type: RESULT

PMID: 32105632 (View on PubMed)

Wang T, Chen R, Liu C, Liang W, Guan W, Tang R, Tang C, Zhang N, Zhong N, Li S. Attention should be paid to venous thromboembolism prophylaxis in the management of COVID-19. Lancet Haematol. 2020 May;7(5):e362-e363. doi: 10.1016/S2352-3026(20)30109-5. Epub 2020 Apr 9. No abstract available.

Reference Type: RESULT

PMID: 32278361 (View on PubMed)

Other Identifiers

2020-01266

Identifier Type: -

Identifier Source: org_study_id