Predictors of Intracranial Hemorrhage in ARDS Patients on ECMO

• Conditions: Extracorporeal Membrane Oxygenation Complication; ARDS, Human
• Interventions: Other: complication versus no complication

• Registration Number: NCT04142775
• Lead Sponsor: Charite University, Berlin, Germany

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 available

Study Timeline

• Study Start: 2019-02-01
• Status Verified: 2019-10
• Study First Submitted: 2019-10-25
• Study First Submitted QC: 2019-10-26
• Last Update Submitted: 2019-10-26
• Study First Posted: 2019-10-29
• Last Update Posted: 2019-10-29
• Primary Completion: 2019-12-31
• Study Completion: 2020-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
intracranial hemorrhage (ICH)	complication versus no complication	ARDS patients treated with ECMO developing ICH

Primary Outcome Measures

Name	Time	Method
mortality	up to 28 days	mortality after ICH/no ICH in ARDS patients with ECMO

Secondary Outcome Measures

Name	Time	Method
ICU stay	up to 28 days	days on ICU
ventilator/ECMO-free days	up to 28 days	Ventilator/ECMO-free days

Trial Locations

Locations (1)

Charite university medicine Berlin; 🇩🇪 Berlin, Germany