NCT04446286

Brief Summary

Describes the cohort of patients receiving ECMO-VV or ECMO-VA in the management of severe ARDS refractory to SARS-CoV-2 in the Strasbourg and Louvain centres

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 all trials

Timeline
Completed

Started Jun 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

Study Start

First participant enrolled

June 18, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 23, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 24, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2020

Completed
Last Updated

October 8, 2021

Status Verified

June 1, 2020

Enrollment Period

2 months

First QC Date

June 23, 2020

Last Update Submit

October 7, 2021

Conditions

Covid-19

Keywords

Respiratory Distress SyndromeSARS-CoV-2Extracorporeal membrane oxygenationECMO-VVECMO-VAVeno-venous ECMO

Outcome Measures

Primary Outcomes (1)

  • Retrospective description of effect of the ECMO-VV or ECMO-VA in the management of severe ARDS refractory in patients of the Strasbourg and Louvain centres with covid-19

    files analysed retrospectily from March 1st, 2020 to August 1st, 2020 will be examined

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with a COVID-19 diagnosis by RT-PCR

You may qualify if:

  • Patient over the age of 18;
  • Diagnostic COVID-19 by RT-PCR;
  • Hospitalisation in resuscitation for the management of complications related to COVID-19
  • Implanted ECMO-VV or VA during hospitalisation;
  • Patient agreeing to participate in the study

You may not qualify if:

  • Sujet who has expressed opposition to participating in the study.
  • Sujet under guardianship or trusteeship
  • Sujet under safeguard of justice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Chirurgie Thoracique Nouvel Hôpital Civil Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

COVID-19Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 23, 2020

First Posted

June 24, 2020

Study Start

June 18, 2020

Primary Completion

August 18, 2020

Study Completion

August 18, 2020

Last Updated

October 8, 2021

Record last verified: 2020-06

Locations

FR(1)