NCT04363528

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2020

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

April 24, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 27, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2021

Completed
Last Updated

July 26, 2022

Status Verified

July 1, 2022

Enrollment Period

8 months

First QC Date

April 23, 2020

Last Update Submit

July 25, 2022

Conditions

Deep Vein Thrombosis

Keywords

Deep Vein Thrombosisdoppler echoSARS-CoV-2ICU

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

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

Doppler EchoOTHER

2 doppler echo will be done at patients hospitalized in ICU and with SARS-CoV-2 pneumopathy at 7 days apart

Doppler Echo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier de Versailles

Le Chesnay, 78150, France

Location

MeSH Terms

Conditions

Venous Thrombosis

Condition Hierarchy (Ancestors)

ThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
coordonator investigator

Study Record Dates

First Submitted

April 23, 2020

First Posted

April 27, 2020

Study Start

April 24, 2020

Primary Completion

December 24, 2020

Study Completion

June 24, 2021

Last Updated

July 26, 2022

Record last verified: 2022-07

Locations

FR(1)