To compare the (cost-)effectiveness of early surgical hematoma evacuation versus a conservative treatment in elderly patients with a traumatic ASDH.
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
- Nervous system, skull and spine therapeutic procedures
- Vascular haemorrhagic disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Functional outcome after 1 year, expressed by the rating on the Extended
Glasgow Outcome Scale (GOS-E)
Secondary outcome
- Functional outcome as expressed on the GOS-E besides the one year measurement
(this includes mortality)
- Disease-specific quality of life as expressed on the QOLIBRI
- Health-related quality of life as expressed on the EuroQol-5D-5L
- Cognitive functioning as expressed on the MOCA
- Direct & indirect costs
- Duration of hospital stay
- Time from event to surgery
- Discharge locations
- Complications (during hospital stay)
- Secondary surgery in both groups
Background summary
The rapidly increasing number of elderly (>= 55 years old) with traumatic brain
injury (TBI) is accompanied by substantial medical and economic consequences.
An intracranial hematoma, specifically an acute subdural hematoma (ASDH), is
the most common injury in elderly with TBI. The surgical versus conservative
treatment of this patient group remains an important clinical and moral
dilemma, since it is in most cases unclear which treatment leads to a better
outcome for the patient. Current guidelines are not based on high-quality
evidence and compliance is low, allowing for large treatment variation in both
Belgium and the Netherlands for patients with a traumatic ASDH. In addition,
elderly are underrepresented in scientific TBI literature and are therefore not
included in current guidelines or prognostic models, leading to major
uncertainty in (neurosurgical) decision- making for this group. As participants
in two large TBI research projects (CENTER-TBI, Net- QuRe), the investigators
observe that the uncertainty regarding treatment of elderly with a traumatic
ASDH will not be solved by the current ongoing studies. Therefore, they
recognize the necessity of undertaking an international, prospective,
multicenter observational study on the (cost- )effectiveness of early surgical
hematoma evacuation versus a conservative treatment in elderly with a traumatic
ASDH.
Study objective
To compare the (cost-)effectiveness of early surgical hematoma evacuation
versus a conservative treatment in elderly patients with a traumatic ASDH.
Study design
An international, prospective, multicenter, observational study.
Intervention
Patients are randomized to either early surgical hematoma evacuation (A) or
conservative management on the ICU or the ward (B). In case of neurological
deterioration during conservative management, delayed surgery can be performed.
The exact neurosurgical technique will be left to the discretion of the
surgeons.
Study burden and risks
Both treatment strategies are already used in current clinical practice as
standard medical care. Therefore, there are no extra risks for patients
participating in the study compared to patients outside the study. Study
participation adds a minimal burden of three follow-up evaluations by visit in
the first year (at 3, 6 and 12 months) and subsequent yearly evaluations by
phone or postal until five years after the injury. Future elderly patients with
a traumatic ASDH will benefit mostly from this study*s results.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
- Age >= 55 years
- History of traumatic brain injury
- Acute subdural hematoma >10mm and/or with a midline shift* >5mm on
radiological imaging (CT-scan)
* Midline shift will be measured as the perpendicular distance between the
septum pellucidum and a line designated the midline on CT-scan in brain
setting.
Exclusion criteria
- Additional epidural hematoma (EDH) or infratentorial (e.g. cerebellar)
intracerebral hemorrhage (ICH)
- Major traumatic abdominal or thoracic injury (each separately defined as an
Abbreviated Injury Scale (AIS) score >= 4) or a *moribund* state at presentation
(e.g. bilaterally absent pupillary responses)
- Known terminal condition resulting in a life expectancy of less than 1 year
- Severe and progressive dementia or cerebral infarction necessitating daily
care in a nursery home in the pre-trauma period
Design
Recruitment
metc-ldd@lumc.nl
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
In other registers
| Register | ID |
|---|---|
| CCMO | NL72116.058.20 |
| OMON | NL-OMON27007 |