Clinical Trials Logo
  1. Home
  2. ARDS, Human
  3. NCT04142775
  4. Details
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
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06444750 - Comparison of the Proteome in ICU Patients in Search for TRALI Biomarkers
Not yet recruiting NCT05306392 - Effects of Induced Moderate Hypothermia on ARDS Patients Under Venovenous ExtraCorporeal Membrane Oxygenation N/A
Terminated NCT04954014 - Pilot Study of Single Dose Bevacizumab as Treatment for Acute Respiratory Distress Syndrome (ARDS) in COVID-19 Patients Phase 2
Completed NCT04274296 - Advisory Lead ARDS Respirator Management
Completed NCT04719182 - Practice of Adjunctive Treatments in Intensive Care Unit Patients With COVID-19
Recruiting NCT03215316 - Screening Expiratory Flow Limitation by Flow-time Curve N/A
Recruiting NCT04115514 - Treatment of ARDS With Instilled T3 Phase 2
Not yet recruiting NCT05061212 - The Mechanism of Extracellular Vesicles Containing Mitochondrial DNA in ARDS Lung Injury Caused by Extrapulmonary Sepsis
Not yet recruiting NCT04556864 - Hemodynamic Impact on Critical Care Patients With Lung Damage Secondary to COVID-19
Completed NCT05693051 - Use of Prone Position Ventilation in Danish Patients With COVID-19 Induced Severe ARDS Treated With VV-ECMO
Recruiting NCT04174014 - Optimal PEEP Titration Combining Transpulmonary Pressure Measurement and Electric Impedance Tomography N/A
Enrolling by invitation NCT06164639 - Potential Biomarkers for Reflux Aspiration-induced Lung Injury.
Terminated NCT05384379 - Efficacy and Safety Evaluation of BZ371B in ARDS Patients Early Phase 1
Completed NCT04375735 - London's Exogenous Surfactant Study for COVID19 Phase 1/Phase 2
Completed NCT06224010 - Respiratory Drive and Inspiratory Effort in COVID-19 Associated ARDS
Not yet recruiting NCT04530188 - Effects of Sevoflurane on Extravascular Lung Water and Pulmonary Vascular Permeability in Patients With ARDS Phase 3
Completed NCT03405038 - Prone Position Impact in ARDS Patients on the Incidence of Central Venous Catheter Colonization
Recruiting NCT05148026 - Regional Citrate Anticoagulation for RRT During V-V ECMO N/A
Recruiting NCT04390360 - Smartphone Application for Initiation of Protective Ventilation. Clinical Impact of Instrumental Dead Space Reduction N/A
Completed NCT06197256 - Cardiac Dysfunction in Critically Ill Covid-19 Patients