Risk of Venous Thromboembolism in Critically Ill Patients With Severe COVID-19

• Sponsor: Hospital Universitari Vall d'Hebron Research Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT04374617
• Collaborator: (none)
• Enrollment: 230
• Locations: 3
• Actual Duration (Days): 30
• Patients Per Site: 76.7
• Patients Per Site Per Month: 77.8

Study Details

Study Description

Brief Summary

Severe COVID-19 patients at a high risk of venous thromboembolism. We studied patients in 2 intensive care units of university hospitals in Barcelona and Badalona, Spain. We performed a cut-off screening of deep venous thrombosis (DVT) with bilateral duplex ultrasound to 230 patients.

Condition or Disease	Intervention/Treatment	Phase
COVID-19; Critical Illness; Venous Thromboembolism; Venous Thromboses; Venous Thromboses, Deep; Venous Thrombosis Pulmonary; Pulmonary Embolism; Pulmonary Embolism and Thrombosis; Sars-CoV2; SARS-CoV Infection	Diagnostic Test: Duplex ultrasound and Computed Tomography Angiography

Detailed Description

SARS-CoV-2 infection has been associated with coagulation disorders and increased risk of venous thromboembolism (VTE). The aim of the study is to determine the cumulative incidence of VTE in critically ill patients with COVID-19 and its impact on prognosis.

Methods Cohort study of critically ill patients due to COVID-19. A bilateral venous compression (CUS) ultrasound screening of the lower extremities was performed during a cut-off period in 2 intensive care units of university hospitals in Spain. Asymptomatic and symptomatic VTE were registered: pulmonary embolism (PE) (diagnosed by CT-angiography) and deep venous thrombosis (DVT). The characteristics of the patients, results of their blood tests and their evolution after 7 days of follow-up were recorded.

Study Design

• Study Type: Observational
• Actual Enrollment: 230 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Risk of Venous Thromboembolism in Critically Ill Patients With Severe COVID-19
• Actual Study Start Date: Apr 1, 2020
• Actual Primary Completion Date: Apr 25, 2020
• Actual Study Completion Date: May 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Venous thromboembolism Patients at risk of venous thromboembolism (deep venous thrombosis and/or pulmonary embolism)	Diagnostic Test: Duplex ultrasound and Computed Tomography Angiography; All venous thromboembolisms suspected will diagnosed with ultrasound and CT-angiography; Other Names: Compression ultrasound (CUS) Ct-Angiography

Outcome Measures

Primary Outcome Measures

1. Venous thromboembolisms [7 days]

   Patients with symptomatic pulmonary embolism confirmed on the CT-angiography and those with a swollen limb and confirmed deep venous thrombosis on compression ultrasound were considered to have "symptomatic venous thromboembolisms". The remaining patients with positive limb ultrasound or CT-angiography were considered to have "asymptomatic venous thrombembolism"

Secondary Outcome Measures

1. Deaths [7 days]

   Deaths from all causes during the follow-up

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients with severe COVID-19 pneumonia admitted to the intensive care unit

Exclusion Criteria:

• Treatment with Extracorporeal membrane oxygenation (ECMO)

• Pregnant or postpartum women

• Under 18 years old

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vall d´Hebron Research Institute VHIR	Barcelona	Catalunya	Spain	08035
2	Hospital Germans Trias i Pujol. Universitat Autònoma de Barcelona	Badalona		Spain	08916
3	Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona	Barcelona		Spain	08035

Sponsors and Collaborators

• Hospital Universitari Vall d'Hebron Research Institute

Investigators

• Principal Investigator: Sergi Bellmunt, MD,PhD, Hospital Vall d'Hebron

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
• ClinicalTrials.gov Identifier: NCT04374617
• Other Study ID Numbers: PR(AG)213/2020
• First Posted: May 5, 2020
• Last Update Posted: May 6, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: COVID-19; Pulmonary Embolism; Thrombosis; Embolism; Thromboembolism; Venous Thromboembolism; Venous Thrombosis; Embolism and Thrombosis; Critical Illness

Study Results

No Results Posted as of May 6, 2020