Subarachnoid Hemorrhage (SAH)
Conditions
Keywords
Subarachnoid hemorrhage, Intracranial hypertension, Intracranial pressure, Diagnostic techniques and procedures, Compliance, Treatment outcome, Intensive care, surgical
Brief summary
The purpose of this study is to determine whether treatment guided also by ICP mean wave amplitude improves outcome compared to international standard care in patients with SAH.
Detailed description
In this study SAH-patients are randomized to treatment based on international standard care (ICP/CPP guided therapy) or intracranial compliance (ICP mean wave amplitude) guided therapy in addition to ICP/CPP guided therapy. Main outcome variables are survival and neurological outcome after 3 and 12 months.
Interventions
DEVICEICP mean wave amplitude
Appropriate measures when ICP mean wave amplitude is to high, e.g. CSF drainage
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subarachnoid hemorrhage, acute * Intracerebral pressure monitoring device inserted
Exclusion criteria
* No intracranial pressure monitoring * Age \< 18 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All cause mortality and neurological outcome | 3 and 12 months |
Secondary
| Measure | Time frame |
|---|---|
| Length of stay (ICU, hospital); complications; effect of treatment modalities on mean ICP, CPP, ICP mean wave amplitude. | Hospital stay |
Countries
Norway
Outcome results
None listed