The objective of the study is to set up and validate a digital neurotraumatology quality registry, to identify the most effective clinical care and to provide high quality evidence in support of treatment recommendations and guidelines.
ID
Source
Brief title
Condition
- Increased intracranial pressure and hydrocephalus
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Outcome measures will include functional outcome, social participation and
heath related quality of life.,
Secondary outcome
Same as primary parameters.
Background summary
There is a lot of discussion about the optimal treatment of traumatic acut
subdural heamatoma and the intraparenchymal contusion in relation with timing
of neurosurgical interventions. Treatments varies in regions and between
practitioners. A comparative effectiveness study isn't done.
Study objective
The objective of the study is to set up and validate a digital
neurotraumatology quality registry, to identify the most effective clinical
care and to provide high quality evidence in support of treatment
recommendations and guidelines.
Study design
Longitudinal prospective observational cohort study with a follow-up of 2
years. Comparative effectiveness research (CER) provides a promising framework
to identify best practices and improve outcome after TBI.
Study burden and risks
There are no risks.
Albinusdreef 2 Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2 Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
Presentation within 24 hours of injury.
Clinical diagnoses traumatic brain injury.
GCS < 13 by presentation ER.
Secundair decrease (GCS < 13) <= 24 hours after presentation on the ER.
Informed Consent obtained according to local and national requirements.
Age 16 year or older.
Exclusion criteria
Severe pre-existing neurological disorder that would confound outcome
assessments.
By presentation a not traumatic cause of decreased consciousness.
Insufficient knowledge of Dutch or English language.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL65064.058.18 |