Status:
COMPLETED
Study for the Improvement of Long-Term Outcome Prediction in Patients in Coma After Cardiac Arrest
Lead Sponsor:
Ludwig-Maximilians - University of Munich
Collaborating Sponsors:
Else Kröner Fresenius Foundation
University Hospital Augsburg
Conditions:
Anoxic-Ischemic Encephalopathy
Eligibility:
All Genders
18-85 years
Brief Summary
The primary objective of HOPE is to improve the accuracy of outcome prediction in anoxic-ischemic encephalopathy following cardiac arrest by bringing under close scrutiny some of the existing methods ...
Detailed Description
HOPE conducts a 2.5-year multicenter prospective cohort study in Germany on outcome prediction in the early stages of coma caused by cerebral hypoxia-ischemia. The main features of the project are: ...
Eligibility Criteria
Inclusion
- Age between 18 and 85 years
- Cause of admission to ICU: cardiac arrest (in or out of hospital)
- Glasgow-Coma-Scale \< 9 at time of study enrolment (3 to 8 days after cardiac arrest)
- Informed consent signed by legal guardian/next-of-kin
Exclusion
- Stroke (as it may interfere with SSEP testing)
- Pre-existing coma/vegetative state/minimally conscious state
- Terminal malignant disease
- Survival in the next 12 months extremely unlikely
- Existing advanced directive that demands cessation of therapy/life support
- Palliative care/withdrawal of life support during treatment at the ICU
- Barbiturate-induced general anesthesia during the first 3 days after cardiac arrest
- Impossibility of assessing current level of consciousness with the Glasgow Coma Scale due to a long-term deep sedation
Key Trial Info
Start Date :
October 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 6 2018
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT02231060
Start Date
October 1 2014
End Date
December 6 2018
Last Update
December 12 2018
Active Locations (16)
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1
Department of Neurology, Klinikum Augsburg
Augsburg, Bavaria, Germany, 86009
2
I. Medizinische Klinik, Klinikum Augsburg
Augsburg, Bavaria, Germany, 86009
3
Schön Klinik Bad Aibling
Bad Aibling, Bavaria, Germany, 83043
4
Dept of Neurology, Asklepios Stadtklinik Bad Tölz
Bad Tölz, Bavaria, Germany, 83646