Prognosis in Neurological Intensive Care Unit Patients (proNICU Cohort)
proNICU
1 other identifier
observational
46
1 country
1
Brief Summary
This study examines the prognostic properties of immune parameters, clinical scores, electrophysiological tests (eeg, ssep, emg, eng) and functional imaging for the prediction of functional outcome one year after treatment on a neurological intensive care unit.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jun 2012
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2011
CompletedFirst Posted
Study publicly available on registry
November 2, 2011
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 3, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 3, 2016
CompletedNovember 29, 2018
November 1, 2018
4.3 years
October 31, 2011
November 28, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Predictive properties of immune parameters (IL6, IL10, mHLA-DR) for functional outcome one year after symptom onset
To evaluate of the predictive properties of immune parameters (IL6, IL10, mHLA-DR) for functional outcome one year after symptom onset
one year after symptom onset
Secondary Outcomes (7)
To evaluate of the predictive properties of clinical scores for functional outcome one year after symptom onset
one year after symptom onset
To evaluate of the predictive properties of electrophysiological measurements one year after symptom onset
one year after symptom onset
To evaluate of the predictive properties of conventional (DTI) and functional imaging (resting state) one year after symptom onset
one year after symptom onset
Transcriptome analyses
one year after symptom onset
Predictive properties of immune parameters in the cerebrovascular fluid for functional outcome one year after symptom onset
one year after symptom onset
- +2 more secondary outcomes
Study Arms (1)
severe neurological diseases
Patients with severe neurological diseases treated on the neurological intensive care unit
Eligibility Criteria
patients with severe neurological diseases treated on a neurological intensive care unit
You may qualify if:
- severe neurological disease making treatment on a neurological intensive care unit necessary
- age ≥ 18
- consent by the patient or the legal representative
You may not qualify if:
- participation in an interventional trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Charite University (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)
Berlin, Germany
Biospecimen
Blood samples (serum, plasma), cerebrovascular fluid
Study Officials
- PRINCIPAL INVESTIGATOR
Andreas Meisel, MD
Charite University Berlin (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Dr. med. Andreas Meisel
Study Record Dates
First Submitted
October 31, 2011
First Posted
November 2, 2011
Study Start
June 1, 2012
Primary Completion
October 3, 2016
Study Completion
October 3, 2016
Last Updated
November 29, 2018
Record last verified: 2018-11