Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 Reliable identification of patients with a possible good outcome, in whom treatment should not be withdrawn, is difficult.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.
In order to identify patients with a good neurological outcome a combination of diagnostic tests is used.
Clinical rating scales
Blood biomarkers
EEG with reactivity testing
Standard 21-electrode montage
Stimuli protocol I: a set of 5 stimuli repeated 3 times
1. Auditory: clapping in hands, 2. Auditory: calling patients name loudly, 3. Visual: passive eye opening, 4. Tactile: nasal tickle, 5. Noxious: sternal rub Each stimuli is applied for a duration of 5 seconds and an interval between stimuli of 30 seconds
Stimuli protocol II: Cognitive-motor dissociation test
MRI-scan
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Glasgow Outcome Scale Extended | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Glasgow Outcome Scale Extended | 12 months |
Not provided
Inclusion Criteria:
All patients that are admitted to the ICU with the following criteria will be eligible for inclusion:
Severe brain injury (GCS ≤ 8) as a result of:
Age ≥ 18 years old
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:
Not provided
Not provided
Not provided
Not provided
All patients with acute severe brain injury admitted to the ICU of at least 18 years old.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wolmet Haksteen, MD | Contact | +31 020 566 9111 | w.e.haksteen@amsterdamumc.nl | |
| Janneke Horn, Prof. dr. | Contact | j.horn@amsterdamumc.nl |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud UMC | Recruiting | Nijmegen | Gelderland | 6525 GA | Netherlands |
Not provided
Not provided
Not provided
Not provided
| Amsterdam UMC | Recruiting | Amsterdam | North Holland | 1105 AZ | Netherlands |
|
| Erasmus MC | Not yet recruiting | Rotterdam | South Holland | 3015 GD | Netherlands |
|
| Haaglanden MC, locatie Westeinde | Recruiting | The Hague | South Holland | 2512 VA | Netherlands |
|
| UMC Groningen | Not yet recruiting | Groningen | 9713 GZ | Netherlands |
|
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D020300 | Intracranial Hemorrhages |
| D013345 | Subarachnoid Hemorrhage |
| D008581 | Meningitis |
| D004660 | Encephalitis |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000090862 | Neuroinflammatory Diseases |
Not provided
Not provided