The University of Freiburg Medical Center Extracorporeal... | NCT05811780

Studies
The University of Freiburg Medical Center Extracorporeal Organ Support Device Registry

NCT05811780

Sponsor

University Hospital Freiburg

Status

Recruiting

Last Update Posted

Apr 13, 2023Actual

Enrollment

1,500Estimated

Phase

Not provided

Conditions

Medical Condition Requiring Extracorporeal Organ Support

Interventions

Not provided

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

Mar 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 29, 2014Actual

Primary Completion Date

Dec 31, 2030Estimated

Completion Date

Dec 31, 2035Estimated

First Submitted Date

Mar 20, 2023

First Submission Date that Met QC Criteria

Mar 31, 2023

First Posted Date

Apr 13, 2023Actual

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

Mar 31, 2023

Last Update Posted Date

Apr 13, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

PD Dr. Alexander Supady, Co-Principal Investigator, University Hospital FreiburgPrincipal Investigator

Lead Sponsor

University Hospital FreiburgOTHER

Collaborators

Not provided

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

A prospective registry collecting pseudonymized clinical and treatment data from all patients treated with extracorporeal organ support (i.e., VV ECMO, VA ECMO, ECPR, Impella, IABP, and others) on the wards of the Department of Interdisciplinary Medical Intensive Care at the Freiburg University Medical Center.

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

Yes

Target Follow-Up Duration

10 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hospital survival	Survival of index hospitalization (yes/no)	30 days

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
Mesenteric ischemia	Occurrence of mesenteric ischemia	30 days
Fluid balance	Patient fluid balance (difference between fluid input and output)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Treatment with any kind of extracorporeal organ support

Exclusion Criteria:

none

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

All patients receiving extracorporeal organ support and being treated in the Department of Interdisciplinary Medical Intensive Care of the Freiburg University Medical Center

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tobias Wengenmayer, Prof. Dr.	Contact	+49761270	35910	tobias.wengenmayer@uniklinik-freiburg.de
Alexander Supady, PD Dr.	Contact	+49761270	73790	alexander.supady@uniklinik-freiburg.de

Overall Officials

Name	Affiliation	Role
Tobias Wengenmayer, Prof. Dr.	University of Freiburg	Study Director
Dawid L Staudacher, PD Dr.	University of Freiburg	Principal Investigator
Paul M Biever, Dr.

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Freiburg Medical Center	Recruiting	Freiburg im Breisgau		79106	Germany

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012128	Respiratory Distress Syndrome
D012131	Respiratory Insufficiency
D012770	Shock, Cardiogenic
D006323	Heart Arrest

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders
D009203	Myocardial Infarction

Browse Leaves

Not provided

Browse Branches

Not provided