Predictors of Intracranial Hemorrhage in ARDS Patients on ECMO

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

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.

Study Overview

• Status: Unknown
• Conditions: ARDS, Human; Extracorporeal Membrane Oxygenation Complication
• Intervention / Treatment: Other: complication versus no complication

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Mario Menk, PD Dr med; Phone Number: +4930450551002; Email: mario.menk@charite.de

Study Locations

• Germany
  • Berlin, Germany
    • Recruiting
    • Charite University Medicine Berlin
    • Contact: Mario Menk, PD Dr med; Phone Number: +4930450551002; Email: mario.menk@charite.de
    • Contact: Oliver Hunsicker, Dr med; Phone Number: +4930450551002; Email: oliver.hunsicker@charite.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
intracranial hemorrhage (ICH); ARDS patients treated with ECMO developing ICH	Other: complication versus no complication; development of ICH
no intracranial hemorrhage; ARDS patients treated with ECMO not developing ICH

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): March 31, 2020

Study Registration Dates

• First Submitted: October 25, 2019
• First Submitted That Met QC Criteria: October 26, 2019
• First Posted (Actual): October 29, 2019

Study Record Updates

• Last Update Posted (Actual): October 29, 2019
• Last Update Submitted That Met QC Criteria: October 26, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Lung Diseases; Hemorrhage; Intracranial Hemorrhages; Respiratory Distress Syndrome
• Other Study ID Numbers: ChariteMM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No