Subarachnoid Hemorrhage (SAH)NCT00248690
ICP Versus Intracranial Compliance Guided Management in SAH
A study testing ICP mean wave amplitude in people with Subarachnoid Hemorrhage (SAH), run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage (SAH)
- What is being tested?
- ICP mean wave amplitude
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2005to Jun 2009
- 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
- Subarachnoid hemorrhage, acute
- Intracerebral pressure monitoring device inserted
Who cannot join
- No intracranial pressure monitoring
- Age < 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intracranial Pressure (ICP) Versus Intracranial Compliance (ICC) Guided Management in Subarachnoid Hemorrhage; - a Prospective, Randomized Trial.
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.
Read the 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.
- Conditions
- Subarachnoid Hemorrhage (SAH)
- Being tested
- ICP mean wave amplitude
- Keywords
- Subarachnoid hemorrhage, Intracranial hypertension, Intracranial pressure, Diagnostic techniques and procedures, Compliance, Treatment outcome, Intensive care, surgical
- Medical subject headings
- Subarachnoid Hemorrhage, Intracranial Hypertension, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICP mean wave amplitudeDevice
Appropriate measures when ICP mean wave amplitude is to high, e.g. CSF drainage
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause mortality and neurological outcome
Measured: 3 and 12 months
Secondary outcomes (1)
Length of stay (ICU, hospital); complications; effect of treatment modalities on mean ICP, CPP, ICP mean wave amplitude.
Measured: Hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2005 (estimated)
- Study startNov 2005
- Primary completionFeb 2009
- Study completionJun 2009
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 Subarachnoid Hemorrhage (SAH)Studies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Gunnar Bentsen, MD, Study director, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00248690
- Sponsor's protocol ID
- 2005-SAHD
- Other IDs
- S-05184
- Status last verified
- Jan 2008
- First submitted
- 25 Oct 2005
- Last updated
- 19 Jan 2011
- Results posted
- No
Publications
Eide PK, Sorteberg A, Bentsen G, Marthinsen PB, Stubhaug A, Sorteberg W. Pressure-derived versus pressure wave amplitude-derived indices of cerebrovascular pressure reactivity in relation to early clinical state and 12-month outcome following aneurysmal subarachnoid hemorrhage. J Neurosurg. 2012 May;116(5):961-71. doi: 10.3171/2012.1.JNS111313. Epub 2012 Feb 10.
PubMed 22324419
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intracranial Pressure (ICP) Versus Intracranial Compliance (ICC) Guided Management in Subarachnoid Hemorrhage; - a Prospective, Randomized Trial.
- ClinicalTrials.gov ID
- NCT00248690
- Acronym / sponsor ID
- 2005-SAHD
- Conditions
- Subarachnoid Hemorrhage (SAH)
- Keywords
- Subarachnoid hemorrhage, Intracranial hypertension, Intracranial pressure, Diagnostic techniques and procedures, Compliance, Treatment outcome, Intensive care, surgical
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Nov 2005
- Primary completion
- Feb 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 4 Nov 2005 (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 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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subarachnoid hemorrhage, acute
- Intracerebral pressure monitoring device inserted
Key exclusion criteria (2 listed)
- No intracranial pressure monitoring
- Age < 18 years
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 |
|---|---|---|
| ICP mean wave amplitudeAppropriate measures when ICP mean wave amplitude is to high, e.g. CSF drainage | Device | – |
Primary outcome
All cause mortality and neurological outcome
Time frame: 3 and 12 months
1 secondary outcome
Length of stay (ICU, hospital); complications; effect of treatment modalities on mean ICP, CPP, ICP mean wave amplitude.
Time frame: Hospital stay
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 19 Jan 2011.
- Derived from this study: PubMed 22324419Eide PK, Sorteberg A, Bentsen G, Marthinsen PB, Stubhaug A, Sorteberg W. Pressure-derived versus pressure wave amplitude-derived indices of cerebrovascular pressure reactivity in relation to early clinical state and 12-month outcome following aneurysmal subarachnoid hemorrhage. J Neurosurg. 2012 May;116(5):961-71. doi: 10.3171/2012.1.JNS111313. Epub 2012 Feb 10.
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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.
Gunnar Bentsen, MD study director
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 ICP mean wave amplitude in people with Subarachnoid Hemorrhage (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 2 inclusion and 2 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 19 Jan 2011. 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?
All cause mortality and neurological outcome (time frame: 3 and 12 months). 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 NCT00248690, 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 19 Jan 2011.