NCT04142775

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
unknown

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

February 1, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 25, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 29, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
Last Updated

October 29, 2019

Status Verified

October 1, 2019

Enrollment Period

11 months

First QC Date

October 25, 2019

Last Update Submit

October 26, 2019

Conditions

ARDS, HumanExtracorporeal Membrane Oxygenation Complication

Outcome Measures

Primary Outcomes (1)

  • mortality

    mortality after ICH/no ICH in ARDS patients with ECMO

    up to 28 days

Secondary Outcomes (2)

  • ICU stay

    up to 28 days

  • ventilator/ECMO-free days

    up to 28 days

Study Arms (2)

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

complication versus no complicationOTHER

development of ICH

intracranial hemorrhage (ICH)

Eligibility Criteria

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

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charite university medicine Berlin

Berlin, Germany

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Central Study Contacts

Mario Menk, PD Dr med

CONTACT

+4930450551002mario.menk@charite.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 25, 2019

First Posted

October 29, 2019

Study Start

February 1, 2019

Primary Completion

December 31, 2019

Study Completion

March 31, 2020

Last Updated

October 29, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)