NCT04338932

Brief Summary

The aim of this study is to investigate the prevalence and possible risk factors of the occurrence of a DVT in 12 intubated and mechanically ventilated COVID-19 patients admitted to the ICU at a single time point (29/03/2020).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

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 7, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2020

Completed
9 days until next milestone

Study Start

First participant enrolled

April 17, 2020

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2020

Completed
Last Updated

May 19, 2020

Status Verified

May 1, 2020

Enrollment Period

28 days

First QC Date

April 7, 2020

Last Update Submit

May 16, 2020

Conditions

COVID-19Deep Vein Thrombosis (DVT)/Thrombophlebitis

Outcome Measures

Primary Outcomes (1)

  • the prevalence of a DVT in patients at the ICU.

    to investigate the prevalence of a DVT in patients at the ICU.

    1 day at ICU

Secondary Outcomes (11)

  • Oxygen partial pressure and Carbon dioxide partial pressure levels in the blood

    1 day at ICU

  • Potassium, Sodium, Calcium, Bicarbonate, Base excess, Lactate levels in the blood

    1 day at ICU

  • glucose, haemoglobin, ureum, creatinine, total bilirubin levels in the blood

    1 day at ICU

  • oxygen saturation, basophils, eosinophils, monocytes, neutrophils, haematocrit and prothrombine levels in the blood

    1 day at ICU

  • white blood cells, red blood cells and platelets in the blood

    1 day at ICU

  • +6 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

12 intubated and mechanically ventilated COVID-19 patients admitted to the ICU at a single time point (29/03/2020).

You may qualify if:

  • intubated and mechanically ventilated COVID-19 patients admitted to the ICU at a single time point (29/03/2020).

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jessa hospital

Hasselt, 3500, Belgium

Location

MeSH Terms

Conditions

COVID-19Venous Thrombosis

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 7, 2020

First Posted

April 8, 2020

Study Start

April 17, 2020

Primary Completion

May 15, 2020

Study Completion

May 15, 2020

Last Updated

May 19, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)