NCT04452422

Brief Summary

Severe SARS-CoV-2 infection, responsible of COVID-19, is accompanied by many venous thromboembolic events. Antithrombotic treatment is the cornerstone of management of many neurovascular diseases (NVDs) and the benefit-risk ratio is crucial to avoid hemorrhagic complications. Therefore, in non-severe COVID-19 patients affected by NVDs, the diagnostic of deep venous thrombosis (DVT) is challenging. Using bedside Doppler ultrasonography (DUS) of lower limbs, this study investigated the rates of DVT in these patients in stroke unit.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

June 23, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 30, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2020

Completed
Last Updated

October 8, 2021

Status Verified

June 1, 2020

Enrollment Period

3 months

First QC Date

June 23, 2020

Last Update Submit

October 7, 2021

Conditions

Deep Venous Thrombosis

Keywords

non-severe COVID-19neurovascular diseasesDoppler ultrasoundDeep venous thrombosisCovid-19SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

  • Number of cumulated deep venous thrombosis among the hospitalization

    Day 7 after admisssion

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with COVID-19 confirmed with RT-PCER and/or chest CT-scan and with acute neurovascular disease defined as transient ischemic attack or acute ischemic stroke or venous cerebral thrombosis or hemorrhagic stroke.

You may qualify if:

  • Age\>18 years
  • COVID-19 confirmed with RT-PCER and/or chest CT-scan
  • Acute neurovascular disease defined as transient ischemic attack or acute ischemic stroke or venous cerebral thrombosis or hemorrhagic stroke.

You may not qualify if:

  • age\<18
  • Other neurovascular diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service Unité Neurovasculaire

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Venous ThrombosisCOVID-19

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2020

First Posted

June 30, 2020

Study Start

June 23, 2020

Primary Completion

September 23, 2020

Study Completion

September 23, 2020

Last Updated

October 8, 2021

Record last verified: 2020-06

Locations

FR(1)