Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Deep Venous Thrombosis in Non-severe COVID-19 Patients Hospitalized for a Neurovascular Pathology (VT-Covid-19)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04452422
Recruitment Status : Recruiting
First Posted : June 30, 2020
Last Update Posted : June 30, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

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.

Condition or disease
Deep Venous Thrombosis

Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Other
Official Title: High Prevalence of Deep Venous Thrombosis in Non-severe COVID-19 Patients Hospitalized for a Neurovascular Pathology
Actual Study Start Date : June 23, 2020
Estimated Primary Completion Date : September 23, 2020
Estimated Study Completion Date : September 23, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Number of cumulated deep venous thrombosis among the hospitalization [ Time Frame: Day 7 after admisssion ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-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.
Criteria
  • Inclusion criteria:

    • 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.
  • Exclusion criteria:

    • age<18
    • Other neurovascular diseases

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04452422


Contacts
Layout table for location contacts
Contact: Olivier ROUYER, MD 33 3 88 12 87 50 olivier.rouyer@chru-strasbourg.fr
Contact: Saïd CHAYER, PhD, HDR 33 3 88 11 66 90 said.chayer@chru-strasbourg.fr

Locations
Layout table for location information
France
Service Unité Neurovasculaire Recruiting
Strasbourg, France, 67091
Contact: Olivier ROUYER, MD    33 3 88 12 87 50    olivier.rouyer@chru-strasbourg.fr   
Contact: Saïd CHAYER, PhD, HDR    33 3 88 11 66 90    said.chayer@chru-strasbourg.fr   
Principal Investigator: Olivier ROUYER, MD         
Sub-Investigator: Bernard GENY, MD, PhD         
Sub-Investigator: Nora PIERRE-PAUL Irène, MD         
Sub-Investigator: Amadou Talibe BALDE, MD         
Sub-Investigator: Daniela BINDILA, MD         
Sub-Investigator: Valérie WOLFF, MD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
Layout table for additonal information
Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT04452422    
Other Study ID Numbers: 7908
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: June 30, 2020
Last Verified: June 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Strasbourg, France:
non-severe COVID-19
neurovascular diseases
Doppler ultrasound
Deep venous thrombosis
Covid-19
SARS-CoV-2
Additional relevant MeSH terms:
Layout table for MeSH terms
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases