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NCT04142775 Clinical Trial

Predictors of Intracranial Hemorrhage in ARDS Patients on ECMO

ARDS, Human Clinical Trial

Official title:
Predictors of Intracranial Hemorrhage in Critically Ill Patients With Acute Lung Failure (ARDS) on Extracorporeal Membrane Oxygenation (ECMO)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04142775
Other study ID # ChariteMM
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 1, 2019
Est. completion date March 31, 2020

Study information
Verified date October 2019
Source Charite University, Berlin, Germany
Contact Mario Menk, PD Dr med
Phone +4930450551002
Email mario.menk@charite.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date March 31, 2020
Est. primary completion date December 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• complication versus no complication
development of ICH

Locations
Country Name City State
Germany Charite university medicine Berlin Berlin

Sponsors (1)
Lead Sponsor Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary mortality mortality after ICH/no ICH in ARDS patients with ECMO up to 28 days
Secondary ICU stay days on ICU up to 28 days
Secondary ventilator/ECMO-free days Ventilator/ECMO-free days up to 28 days
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