ARDS, HumanNCT04142775
Predictors of Intracranial Hemorrhage in ARDS Patients on ECMO
An observational study of ARDS, Human and Extracorporeal Membrane Oxygenation Complication, run by Charite University, Berlin, Germany at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS, Human, Extracorporeal Membrane Oxygenation Complication
- What is being tested?
- complication versus no complication
- How many people
- 1,000 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2019to 31 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: critically ill patients on the ICU with acute lung failure (ARDS) in a German regional ARDS referral center
Who may be able to join
- ARDS following Berlin definition (mild, moderate, severe)
- ECMO therapy (veno-venous cannulation)
Who cannot join
- ECMO, other than VV
- ICH at initiation of ECMO
- no cerebral CT scan at any time
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Charite university medicine Berlin
Berlin
Mario Menk, PD Dr med, +4930450551002, mario.menk@charite.de
Oliver Hunsicker, Dr med, +4930450551002, oliver.hunsicker@charite.de
About this study
Official title: 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.
- Being tested
- complication versus no complication
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
complication versus no complicationOther
development of ICH
| Study group | Role | What they receive |
|---|---|---|
| intracranial hemorrhage (ICH) | ARDS patients treated with ECMO developing ICH Receives: Other: complication versus no complication | |
| no intracranial hemorrhage | ARDS patients treated with ECMO not developing ICH |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality
mortality after ICH/no ICH in ARDS patients with ECMO
Measured: up to 28 days
Secondary outcomes (2)
ICU stay
days on ICU
Measured: up to 28 days
ventilator/ECMO-free days
Ventilator/ECMO-free days
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2019
- Study start1 Feb 2019
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS, HumanStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Menk, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04142775
- Sponsor's protocol ID
- ChariteMM
- Status last verified
- Oct 2019
- First submitted
- 25 Oct 2019
- Last updated
- 29 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Intracranial Hemorrhage in Critically Ill Patients With Acute Lung Failure (ARDS) on Extracorporeal Membrane Oxygenation (ECMO)
- ClinicalTrials.gov ID
- NCT04142775
- Acronym / sponsor ID
- ChariteMM
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 29 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intracranial hemorrhage (ICH) | – | Other: complication versus no complicationARDS patients treated with ECMO developing ICH |
| no intracranial hemorrhage | – | –ARDS patients treated with ECMO not developing ICH |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- critically ill patients on the ICU with acute lung failure (ARDS) in a German regional ARDS referral center
Key inclusion criteria (2 listed)
- ARDS following Berlin definition (mild, moderate, severe)
- ECMO therapy (veno-venous cannulation)
Key exclusion criteria (3 listed)
- ECMO, other than VV
- ICH at initiation of ECMO
- no cerebral CT scan at any time
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| complication versus no complicationdevelopment of ICH | Other | intracranial hemorrhage (ICH) |
Primary outcome
mortality
Time frame: up to 28 days
mortality after ICH/no ICH in ARDS patients with ECMO
2 secondary outcomes
ICU stay
Time frame: up to 28 days
ventilator/ECMO-free days
Time frame: up to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ARDS, Human and Extracorporeal Membrane Oxygenation Complication, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mario Menk, PD Dr med (+4930450551002, mario.menk@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality (time frame: up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2019.