Bicentric Study on the Use of ECMO-VV or VA for Severe AR... | NCT04446286

Studies
Bicentric Study on the Use of ECMO-VV or VA for Severe ARDS Associated With Covid-19

NCT04446286

Sponsor

University Hospital, Strasbourg, France

Status

Completed

Last Update Posted

Oct 8, 2021Actual

Enrollment

50Actual

Phase

Not provided

Conditions

Covid-19

Interventions

Not provided

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

Jun 2020

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

Jun 18, 2020Actual

Primary Completion Date

Aug 18, 2020Actual

Completion Date

Aug 18, 2020Actual

First Submitted Date

Jun 23, 2020

First Submission Date that Met QC Criteria

Jun 23, 2020

First Posted Date

Jun 24, 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

Oct 7, 2021

Last Update Posted Date

Oct 8, 2021Actual

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

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Not provided

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

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service de Chirurgie Thoracique Nouvel Hôpital Civil Hôpitaux Universitaires de Strasbourg		Strasbourg		67091	France

Condition Browse Module

MeSH Terms

ID	Term
D000086382	COVID-19
D012128	Respiratory Distress Syndrome

Ancestor Terms

ID	Term
D011024	Pneumonia, Viral
D011014	Pneumonia
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided