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Incidence of Deep Vein Thrombosis at Doppler Echo in Covid-19 Patients With SARS-Cov-2 Pneumopathy Hospitalized in ICU (COVIDOP-DVT)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04363528
Recruitment Status : Active, not recruiting
First Posted : April 27, 2020
Last Update Posted : August 5, 2021
Sponsor:
Information provided by (Responsible Party):
Aurelien Maurizot, Versailles Hospital

Study Description
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Brief Summary:

The main objective of the study is to determine the incidence of deep vein thromboses at Doppler echo in patients with SARS-Cov-2 pneumopathy upon their entry into ICU and after 7 days of hospitalization in ICU.

This is a monocentric interventional study (RIPH 2).


Condition or disease Intervention/treatment Phase
Deep Vein Thrombosis Other: Doppler Echo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Incidence of Deep Vein Thrombosis at Doppler Echo in Patients With SARS-Cov-2 Pneumopathy Hospitalized in ICU
Actual Study Start Date : April 24, 2020
Actual Primary Completion Date : December 30, 2020
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Doppler Echo
patients will have a Doppler Echo when they enter ICU (within 48 hours) and a second Doppler Echo 7 days later
 Other: Doppler Echo
2 doppler echo will be done at patients hospitalized in ICU and with SARS-CoV-2 pneumopathy at 7 days apart


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Deep Vein Thrombosis at Doppler Echo in Patients With SARS-Cov-2 Pneumopathy Hospitalized in ICU [ Time Frame: Day 0 ]
    Deep vein thrombosis at Doppler echo

  2. Incidence of Deep Vein Thrombosis at Doppler Echo in Patients With SARS-Cov-2 Pneumopathy Hospitalized in ICU [ Time Frame: Day 7 ]
    Deep vein thrombosis at Doppler echo


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient > or =18 years
  • Hospitalization in intensive care
  • PCR COVID 19+ or compatible clinical signs (fever, cough, myalgia, asthenia, loss of taste, anosmia) associated with compatible radiological signs

Exclusion Criteria:

  • Pregnancy in progress
  • Patient <18 years
  • Patients deprived of freedoms or under guardianship
  • Patient or family opponent of protocol participation
  • patient on curative anticoagulant for more than 48H00
  • impossible Venous Doppler Echo
Contacts and Locations
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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): NCT04363528


Locations
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France
Centre Hospitalier de Versailles
Le Chesnay, France, 78150
Sponsors and Collaborators
Versailles Hospital
More Information
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Responsible Party: Aurelien Maurizot, coordonator investigator, Versailles Hospital
ClinicalTrials.gov Identifier: NCT04363528    
Other Study ID Numbers: P20/08_COVIDOP-DVT
First Posted: April 27, 2020    Key Record Dates
Last Update Posted: August 5, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aurelien Maurizot, Versailles Hospital:
Deep Vein Thrombosis
doppler echo
SARS-CoV-2
ICU
Additional relevant MeSH terms:
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Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases