Therapy and Outcome of Prolonged Veno-venous ECMO Therapy... | NCT05338593

Studies
Therapy and Outcome of Prolonged Veno-venous ECMO Therapy of Critically Ill ARDS Patients.

NCT05338593

Sponsor

Goethe University

Status

Completed

Last Update Posted

Aug 29, 2023Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Extracorporeal Membrane Oxygenation Complication
Outcome, Fatal

Interventions

Outcome

Countries

Germany

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

Aug 2023

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

May 1, 2022Actual

Primary Completion Date

May 1, 2023Actual

Completion Date

May 15, 2023Actual

First Submitted Date

Apr 14, 2022

First Submission Date that Met QC Criteria

Apr 14, 2022

First Posted Date

Apr 21, 2022Actual

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

Aug 28, 2023

Last Update Posted Date

Aug 29, 2023Actual

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

In the context of the coronavirus (COVID-19) pandemic, healthcare systems worldwide faced an unprecedented shortage of severe ARDS. Critically affected patients were treated with veno-venous extracorporeal membrane oxygenation (VV-ECMO) for complete respiratory failure early in the pandemic. Due to a shortage of resources in the sense of terminal equipment and adequately trained personnel with appropriate expertise in many countries and regions, a strict selection of suitable patients was made. Repeatedly, it was observed that patients under VV-ECMO also needed several weeks to recover sufficiently to generate device sufficient gas exchange. Due to the scarcity of VV-ECMO resources outside of the pandemic, the question arose whether a prolonged therapy still holds a sufficient prospect of success and what the course of treatment of such patients would be like.

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

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
prolonged veno-venous extracorporeal membrane oxygenation		Critically affected patients treated with veno-venous extracorporeal membrane oxygenation (VV-ECMO). Based on severe acute respiratory distress syndrome (ARDS) and prolonged therapy for more than 2 weeks.	Other: Outcome

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Outcome	Other	Mortality rate of prolonged therapy.	prolonged veno-venous extracorporeal membrane oxygenation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Mortality	Mortality rate under ongoing veno-venous extracorporeal membrane oxygenation over time	During intensive care treatment (Usually within 25 weeks)

Secondary Outcomes

Measure	Description	Time Frame
Major bleeding	Number of patients with critical bleeding events during therapy, needing red blood cell transfusion	During intensive care treatment (Usually within 25 weeks)
critical device error

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

veno-venous extracorporeal membrane oxygenation

Exclusion Criteria:

veno-arterial extracorporeal membrane oxygenation

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

Critically affected patients treated with veno-venous extracorporeal membrane oxygenation (VV-ECMO). Based on severe acute respiratory distress syndrome (ARDS) and prolonged therapy for more than 2 weeks.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Armin N Flinspach, M.D.	JWGoethe University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Frankfurt		Frankfurt am Main	Hesse	60590	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Sharing patient data is not possible due to national and local legal restrictions.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided