Back to resultsIncidence of Deep Vein Thrombosis at Doppler Echo in Covid-19 Patients With SARS-Cov-2 Pneumopathy Hospitalized in ICU (COVIDOP-DVT)
Primary Purpose
Deep Vein Thrombosis
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Doppler Echo
Sponsored by
About this trial
This is an interventional supportive care trial for Deep Vein Thrombosis focused on measuring Deep Vein Thrombosis, doppler echo, SARS-CoV-2, ICU
Eligibility 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
Sites / Locations
- Centre Hospitalier de Versailles
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Doppler Echo
Arm Description
patients will have a Doppler Echo when they enter ICU (within 48 hours) and a second Doppler Echo 7 days later
Outcomes
Primary Outcome Measures
Incidence of Deep Vein Thrombosis at Doppler Echo in Patients With SARS-Cov-2 Pneumopathy Hospitalized in ICU
Deep vein thrombosis at Doppler echo
Incidence of Deep Vein Thrombosis at Doppler Echo in Patients With SARS-Cov-2 Pneumopathy Hospitalized in ICU
Deep vein thrombosis at Doppler echo
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04363528
Brief Title
Incidence of Deep Vein Thrombosis at Doppler Echo in Covid-19 Patients With SARS-Cov-2 Pneumopathy Hospitalized in ICU
Acronym
COVIDOP-DVT
Official Title
Incidence of Deep Vein Thrombosis at Doppler Echo in Patients With SARS-Cov-2 Pneumopathy Hospitalized in ICU
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 24, 2020 (Actual)
Primary Completion Date
December 24, 2020 (Actual)
Study Completion Date
June 24, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Versailles Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Deep Vein Thrombosis
Keywords
Deep Vein Thrombosis, doppler echo, SARS-CoV-2, ICU
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Doppler Echo
Arm Type
Other
Arm Description
patients will have a Doppler Echo when they enter ICU (within 48 hours) and a second Doppler Echo 7 days later
Intervention Type
Other
Intervention Name(s)
Doppler Echo
Intervention Description
2 doppler echo will be done at patients hospitalized in ICU and with SARS-CoV-2 pneumopathy at 7 days apart
Primary Outcome Measure Information:
Title
Incidence of Deep Vein Thrombosis at Doppler Echo in Patients With SARS-Cov-2 Pneumopathy Hospitalized in ICU
Description
Deep vein thrombosis at Doppler echo
Time Frame
Day 0
Title
Incidence of Deep Vein Thrombosis at Doppler Echo in Patients With SARS-Cov-2 Pneumopathy Hospitalized in ICU
Description
Deep vein thrombosis at Doppler echo
Time Frame
Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Centre Hospitalier de Versailles
City
Le Chesnay
ZIP/Postal Code
78150
Country
France
12. IPD Sharing Statement
Learn more about this trial
Incidence of Deep Vein Thrombosis at Doppler Echo in Covid-19 Patients With SARS-Cov-2 Pneumopathy Hospitalized in ICU
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