acquired brain injury Traumatic brain injury
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Severe or moderate TBI (Glasgow Coma Scale of 3-12 measured at trauma site or the Emergency Department). - Admission to the ICU. - Age 18 years or older.
Exclusion criteria
Exclusion criteria: - Patients after cardiopulmonary resuscitation with suspected postanoxic encephalopathy. - Earlier hospitalization for TBI or stroke without full neurological recovery. - Any progressive brain illness, such as a brain tumour or neurodegenerative disease. - A limited life expectancy (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary study parameters are: - EEG measurements during the first seven days of ICU admission - TCD measurements, performed twice a day during the first week - ICP measurement (on indication) - CT brain scan at admission - CT brain perfusion scan at day 1 and day 7 (6-8) The GOSE at 12 months (obtained by telephone), will be used as the primary outcome parameter. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secundary study parameters are: - Basic trauma and clinical data, including: age, sex, injury characteristics, initial GCS, GCS during ICU admission, pupillary abnormalities, pre-injury morbidity, haemodynamics, use of vasopressors (cumulative dose), saturation and glucose levels. - CT and MRI data obtained for routine clinical practise Secondary outcome parameters are: - neurological outcome evaluated by the GOSE at hospital discharge and 6 months. | — |
Countries
Netherlands