Incidence of Deep Vein Thrombosis at Doppler Echo in Covi... | NCT04363528

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

NCT04363528

Sponsor

Versailles Hospital

Status

Completed

Last Update Posted

Jul 26, 2022Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Deep Vein Thrombosis

Interventions

Doppler Echo

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 24, 2020Actual

Primary Completion Date

Dec 24, 2020Actual

Completion Date

Jun 24, 2021Actual

First Submitted Date

Apr 23, 2020

First Submission Date that Met QC Criteria

Apr 24, 2020

First Posted Date

Apr 27, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 25, 2022

Last Update Posted Date

Jul 26, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Doppler Echo	Other	patients will have a Doppler Echo when they enter ICU (within 48 hours) and a second Doppler Echo 7 days later	Other: Doppler Echo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Doppler Echo	Other	2 doppler echo will be done at patients hospitalized in ICU and with SARS-CoV-2 pneumopathy at 7 days apart	Doppler Echo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of Deep Vein Thrombosis at Doppler Echo in Patients With SARS-Cov-2 Pneumopathy Hospitalized in ICU	Deep vein thrombosis at Doppler echo	Day 0
Incidence of Deep Vein Thrombosis at Doppler Echo in Patients With SARS-Cov-2 Pneumopathy Hospitalized in ICU	Deep vein thrombosis at Doppler echo	Day 7

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier de Versailles		Le Chesnay		78150	France

Condition Browse Module

MeSH Terms

ID	Term
D020246	Venous Thrombosis

Ancestor Terms

ID	Term
D013927	Thrombosis
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided