Effect of Early Rehabilitation in Patients With Acute Subarachnoid Hemorrhage
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 171
- Locations
- 2
- Primary Endpoint
- Glasgow Coma Scale (GCS)
Study Overview
Brief Summary
The study's main objective will be to assess which effect early initiated rehabilitation has on the frequency of complications and the level of physical and cognitive functioning after aneurysmal subarachnoid hemorrhage (SAH).
To this end the following aspects will be investigated:
The frequency of complications (with special emphasis on pulmonary complications,thromboembolic events, cerebral vasospasm, unintended discontinuation of drains and lines)
- Length of stay in hospitals and socio-economic impact
- Physical and cognitive function in the early and chronic phase after SAH
- Health-related quality of life and participation in society in the chronic phase
Detailed Description
Oslo University Hospital (OUS) is the primary hospital for Health Region South-East regarding treatment of patients with SAH. Approximately 120 patients are referred annually. OUS,Rikshospitalet, Dept of Neurosurgery offers 24/7 service of surgical and vascular aneurysm repair performed by a dedicated vascular team.
Patients admitted in 2012 are treated in accordance to the standard institutional protocol plus an early rehabilitation model adapted to SAH, while patients admitted in 2011 who did not receive any early rehabilitation, but apart from that were treated identically, serve as a control group.
All patients admitted to the intermediate unit at OUS in 2011 and 2012 with aneurysmal SAH and repaired aneurysm will be invited to participate in this study. Examination of the patients from both 2011 and 2012 will be performed as part of routine, neurosurgical follow- up which is in the early phase at 3-6 months and in the chronic phase at least 12 months post SAH. Exclusion criteria for participation in the study: unsecured ruptured aneurysm, symptomatic aneurysm without rupture, previous SAH or brain injury, diagnosis of a neurodegenerative disorder, patients from other health regions or tourists, patients that were treated at the intensive care unit (ICU )only.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All patients admitted to the intermediate unit at OUS in 2011 and 2012 with aneurysmal SAH and repaired aneurysm will be invited to participate in this study.
Exclusion Criteria
- •Unsecured ruptured aneurysm,
- •Symptomatic aneurysm without rupture
- •Previous SAH or brain injury, diagnosis of a neurodegenerative disorder
- •Patients from other health regions or tourists
- •Patients that were treated at the intensive care unit (ICU )only.
Outcomes
Primary Outcomes
Glasgow Coma Scale (GCS)
Time Frame: up to 10 weeks
Secondary Outcomes
- Disability Rating Scale (DRS)(3-6 and 12 months after SAH)
- High Level Mobility Assessment Tool (HIMAT)(3-6 and 12 months after SAH)
- Glasgow Outcome Scale Extended (GOSE)(3-6 months and 12 months after SAH)
- Functional Independence Measure (FIM)(3-6 months and 12 months after SAH)
- Coma Recovery Scale (CRS)(3-6 and 12 months after SAH)
Investigators
Tanja Karic
medical doctor
Oslo University Hospital