Predictors of Intracranial Hemorrhage in ARDS Patients on... | NCT04142775

Studies
Predictors of Intracranial Hemorrhage in ARDS Patients on ECMO

NCT04142775

Sponsor

Charite University, Berlin, Germany

Status

Unknown status

Last Update Posted

Oct 29, 2019Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

ARDS, Human
Extracorporeal Membrane Oxygenation Complication

Interventions

complication versus no complication

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

Oct 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2019Actual

Primary Completion Date

Dec 31, 2019Estimated

Completion Date

Mar 31, 2020Estimated

First Submitted Date

Oct 25, 2019

First Submission Date that Met QC Criteria

Oct 26, 2019

First Posted Date

Oct 29, 2019Actual

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 26, 2019

Last Update Posted Date

Oct 29, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mario Menk, Principal Investigator, Charite University, Berlin, GermanyPrincipal Investigator

Lead Sponsor

Charite University, Berlin, GermanyOTHER

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

Intracranial hemorrhage is is a rare, but critical incident in patients with acute lung failure undergoing ECMO therapy. Predictors of intracranial hemorrhage are yet to be defined to identify patients at (high) risk. This retrospective analysis investigates the predictive value and validity of parameters and specific risk factors of critically ill ARDS patients treated with ECMO.

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

1,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
intracranial hemorrhage (ICH)		ARDS patients treated with ECMO developing ICH	Other: complication versus no complication
no intracranial hemorrhage		ARDS patients treated with ECMO not developing ICH

Interventions

Name	Type	Description	Arm Group Labels	Other Names
complication versus no complication	Other	development of ICH	intracranial hemorrhage (ICH)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
mortality	mortality after ICH/no ICH in ARDS patients with ECMO	up to 28 days

Secondary Outcomes

Measure	Description	Time Frame
ICU stay	days on ICU	up to 28 days
ventilator/ECMO-free days	Ventilator/ECMO-free days	up to 28 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ARDS following Berlin definition (mild, moderate, severe)
ECMO therapy (veno-venous cannulation)

Exclusion Criteria:

ECMO, other than VV
ICH at initiation of ECMO
no cerebral CT scan at any time

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 ill patients on the ICU with acute lung failure (ARDS) in a German regional ARDS referral center

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mario Menk, PD Dr med	Contact	+4930450551002		mario.menk@charite.de

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charite university medicine Berlin	Recruiting	Berlin			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

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders

Browse Leaves

Not provided

Browse Branches

Not provided