SAHSAHNCT01656317
Rehabilitation of Patients After Subarachnoid Hemorrhage
A study testing Early multidisciplinary rehabilitation in people with SAH, run by Oslo University Hospital at 1 site in Norway.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SAH
- What is being tested?
- Early multidisciplinary rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 171 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2012to 20 Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Early Rehabilitation in Patients With Acute Subarachnoid Hemorrhage
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
Read the 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.
- Conditions
- SAH
- Being tested
- Early multidisciplinary rehabilitation
- Keywords
- SAH, Early rehabilitation, Mobilisation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early multidisciplinary rehabilitationOther
Multidisciplinary rehabilitation consist of individualized stimulation and mobilisation.
The multidisciplinary team consists of a physician, a nurse, a physiotherapist, an occupational therapist and a clinical neuropsychologist.
| Study group | Role | What they receive |
|---|---|---|
| Mobilisation of patients after SAH | Active comparator | Patients which were treated after SAH in 2012 will receive early multidisciplinary rehabilitation consist of individualized stimulation and mobilisation.
Mobilisation will be initiated and completed according to mobilisations guidelines which are developed and adjusted to the patients in early stage after aneurysmal SAH. Receives: Other: Early multidisciplinary rehabilitation |
| Patients after SAH from 2011 | No intervention | Patients after SAH from 2011 which did not receive early rehabilitation and mobilisation will be followed up 3-6 annd 12 months after SAH and outcome measures compared with patients from 2011. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glasgow Coma Scale (GCS)
Measured: up to 10 weeks
Secondary outcomes (5)
Glasgow Outcome Scale Extended (GOSE)
Measured: 3-6 months and 12 months after SAH
Functional Independence Measure (FIM)
Measured: 3-6 months and 12 months after SAH
Coma Recovery Scale (CRS)
Measured: 3-6 and 12 months after SAH
Disability Rating Scale (DRS)
Measured: 3-6 and 12 months after SAH
High Level Mobility Assessment Tool (HIMAT)
Measured: 3-6 and 12 months after SAH
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2012 (estimated)
- Study start1 Jan 2012
- Primary completion27 Feb 2014
- Study completion20 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SAHStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tanja Karic, Oslo University Hospital
- Investigators
- Tanja Karic, MD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01656317
- Sponsor's protocol ID
- 2011/2189.
- Other IDs
- ID:2011/2189.
- Acronym
- SAH
- Status last verified
- Mar 2017
- First submitted
- 12 Jul 2012
- Last updated
- 15 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Karic T, Roe C, Nordenmark TH, Becker F, Sorteberg W, Sorteberg A. Effect of early mobilization and rehabilitation on complications in aneurysmal subarachnoid hemorrhage. J Neurosurg. 2017 Feb;126(2):518-526. doi: 10.3171/2015.12.JNS151744. Epub 2016 Apr 8.
PubMed 27058204
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Rehabilitation in Patients With Acute Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT01656317
- Acronym / sponsor ID
- SAH / 2011/2189.
- Conditions
- SAH
- Keywords
- SAH, Early rehabilitation, Mobilisation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 171 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 27 Feb 2014 (actual)
- Study completion
- 20 Dec 2015 (actual)
- First posted
- 2 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mobilisation of patients after SAH | Active comparator | Other: Early multidisciplinary rehabilitationPatients which were treated after SAH in 2012 will receive early multidisciplinary rehabilitation consist of individualized stimulation and mobilisation. Mobilisation will be initiated and completed according to mobilisations guidelines which are developed and adjusted to the patients in early stage after aneurysmal SAH. |
| Patients after SAH from 2011 | No intervention | –Patients after SAH from 2011 which did not receive early rehabilitation and mobilisation will be followed up 3-6 annd 12 months after SAH and outcome measures compared with patients from 2011. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early multidisciplinary rehabilitationMultidisciplinary rehabilitation consist of individualized stimulation and mobilisation. The multidisciplinary team consists of a physician, a nurse, a physiotherapist, an occupational therapist and a clinical neuropsychologist. | Other | Mobilisation of patients after SAH |
Primary outcome
Glasgow Coma Scale (GCS)
Time frame: up to 10 weeks
5 secondary outcomes
Glasgow Outcome Scale Extended (GOSE)
Time frame: 3-6 months and 12 months after SAH
Functional Independence Measure (FIM)
Time frame: 3-6 months and 12 months after SAH
Coma Recovery Scale (CRS)
Time frame: 3-6 and 12 months after SAH
Disability Rating Scale (DRS)
Time frame: 3-6 and 12 months after SAH
High Level Mobility Assessment Tool (HIMAT)
Time frame: 3-6 and 12 months after SAH
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2017.
- Derived from this study: PubMed 27058204Karic T, Roe C, Nordenmark TH, Becker F, Sorteberg W, Sorteberg A. Effect of early mobilization and rehabilitation on complications in aneurysmal subarachnoid hemorrhage. J Neurosurg. 2017 Feb;126(2):518-526. doi: 10.3171/2015.12.JNS151744. Epub 2016 Apr 8.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tanja Karic, MD principal investigator
Oslo University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early multidisciplinary rehabilitation in people with SAH, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgow Coma Scale (GCS) (time frame: up to 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01656317, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2017.