Stroke Clinical Trial
— IMPROVE-DOCOfficial title:
Improving Diagnosis and Prediction of Outcome in Patients With Severe Disorders of Consciousness
Patients with acute severe brain injury are usually admitted to the Intensive Care Unit. A substantial proportion of these patients will have disorders of consciousness (DOC) after interruption of sedation. It is difficult to reliably predict neurological outcome in these patients. Dependent on the extent of permanently damaged brain areas, DOC in patients with acute severe brain injury may improve or persist, eventually evolving into a minimal conscious state (MCS) or unresponsive wakefulness syndrome (UWS). These conditions are accompanied by long term severe disability. In current practice, the decision to withdraw life-sustaining support is made by interpreting the results of repeated bedside neurological examination and conventional CT-brain imaging. Reliable identification of patients with a possible good outcome, in whom treatment should not be withdrawn, is difficult. In this prospective observational cohort study we aim to identify patients with a good neurological outcome.
Status | Recruiting |
Enrollment | 160 |
Est. completion date | September 1, 2025 |
Est. primary completion date | January 1, 2025 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: All patients that are admitted to the ICU with the following criteria will be eligible for inclusion: 1. Severe brain injury (GCS = 8) as a result of: 1. Traumatic brain injury 2. Ischemic cerebrovascular accident 3. Intracranial hemorrhage 4. Meningo-encephalitis 5. Subarachnoid hemorrhage 2. Age = 18 years old 3. Written informed consent from legal representatives Exclusion Criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - Absence of informed consent - Moribund at ICU admission - Progressive neurodegenerative disease - Pre-admission life expectancy = 6 months based on comorbidity - GCS has been > 8 prior to inclusion - Impossible to include within 24 hours after brain injury |
Country | Name | City | State |
---|---|---|---|
Netherlands | Amsterdam UMC | Amsterdam | Noord-Holland |
Netherlands | Haaglanden MC, locatie Westeinde | Den Haag | Zuid-Holland |
Netherlands | UMC Groningen | Groningen | |
Netherlands | Radboud UMC | Nijmegen | Gelderland |
Netherlands | Erasmus MC | Rotterdam | Zuid-Holland |
Lead Sponsor | Collaborator |
---|---|
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Glasgow Outcome Scale Extended | 6 months | ||
Secondary | Glasgow Outcome Scale Extended | 12 months |
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