Aneurysmal Subarachnoid HemorrhageNCT02026596
SpareBrain - Mechanisms and Prevention of Secondary Brain Injury in Subarachnoid Haemorrhage
An observational study of Aneurysmal Subarachnoid Hemorrhage, run by Tampere University Hospital at 1 site in Finland.
Trial summary
Subarachnoidal hemorrhage (SAH) is a cause of long-term disability and death. Annually about 1000 people in Finland suffer from SAH, their average age being under 50 years. SAH has a mortality rate of 12 % acutely and 40 % of patients die within a month from admission to hospital. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aneurysmal Subarachnoid Hemorrhage
- What is being tested?
- Magnetic resonance imaging and Cerebral microdialysis catheter insertion
- Type of treatment
- Surgery or procedure
- How many people
- 61 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2013to Dec 2016
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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
Study population: Patients suffering from aneurysmal subarachnoid haemorrhage
Who may be able to join
- aneurysmal subarachnoid haemorrhage
Who cannot join
- age under 18 years
- pregnant
- moribund patient
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study on Mechanisms and Prevention of Secondary Brain Injury in Subarachnoid Haemorrhage
Subarachnoidal hemorrhage (SAH) is a cause of long-term disability and death. Annually about 1000 people in Finland suffer from SAH, their average age being under 50 years. SAH has a mortality rate of 12 % acutely and 40 % of patients die within a month from admission to hospital. In addition, 30 % of the surviving patients remain with neurological deficits. Most survivors of the primary insult suffer from secondary injury during the first 2-3 weeks from the insult.
Despite the advances in neurosurgical and -radiological techniques and intensive care, the mortality and morbidity rates in SAH have not changed in recent years. There is still only limited understanding of the mechanisms of secondary insults causing brain injury after SAH.
In this study the investigators are aiming to clarify the timescale and mechanisms contributing to the secondary insults. The investigators also explore usability of novel biomarkers to guide treatment of the patients suffering from SAH.
Read the detailed description
Subarachnoidal hemorrhage (SAH) is a cause of long-term disability and death. Annually about 1000 people in Finland suffer from SAH, their average age being under 50 years. SAH has a mortality rate of 12 % acutely and 40 % of patients die within a month from admission to hospital. In addition, 30 % of the surviving patients remain with neurological deficits. Most survivors of the primary insult suffer from secondary injury during the first 2-3 weeks from the insult.
Despite the advances in neurosurgical and -radiological techniques and intensive care, the mortality and morbidity rates in SAH have not changed in recent years. There is still only limited understanding of the mechanisms of secondary insults causing brain injury after SAH.
In this study the investigators are aiming to clarify the timescale and mechanisms contributing to the secondary insults. The investigators also explore usability of novel biomarkers to guide treatment of the patients suffering from SAH.
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Being tested
- Magnetic resonance imaging, Cerebral microdialysis catheter insertion
- Keywords
- subrachnoid hemorrhage, secondary brain injury
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imagingProcedure or surgery
Cerebral microdialysis catheter insertionProcedure or surgery
Is inserted only when invasive intracranial pressure monitoring is required. The same route with pressure probe is used for insertion.
| Study group | Role | What they receive |
|---|---|---|
| aSAH patients | Patients suffering from aneurysmal subarachnoid haemorrhage Receives: Procedure: Magnetic resonance imaging; Procedure: Cerebral microdialysis catheter insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuroradiologically confirmed secondary injury lesions
Neuroradiological imaging (CT/MRI) is performed when clinically indicated and at 2 weeks after primary insult.
Measured: up to 2 weeks after the primary insult
Secondary outcomes (1)
Neurological outcome of the patient
Neurological outcome is evaluated with modified Rankin Scale at 6 months.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2014 (estimated)
- Study startMar 2013
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aneurysmal Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Tampere 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02026596
- Sponsor's protocol ID
- TampereUH
- Status last verified
- Oct 2017
- First submitted
- 25 Nov 2013
- Last updated
- 31 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on Mechanisms and Prevention of Secondary Brain Injury in Subarachnoid Haemorrhage
- ClinicalTrials.gov ID
- NCT02026596
- Acronym / sponsor ID
- TampereUH
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Keywords
- subrachnoid hemorrhage, secondary brain injury
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 3 Jan 2014 (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.
Subarachnoidal hemorrhage (SAH) is a cause of long-term disability and death. Annually about 1000 people in Finland suffer from SAH, their average age being under 50 years. SAH has a mortality rate of 12 % acutely and 40 % of patients die within a month from admission to hospital. In addition, 30 % of the surviving patients remain with neurological deficits. Most survivors of the primary insult suffer from secondary injury during the first 2-3 weeks from the insult.
Despite the advances in neurosurgical and -radiological techniques and intensive care, the mortality and morbidity rates in SAH have not changed in recent years. There is still only limited understanding of the mechanisms of secondary insults causing brain injury after SAH.
In this study the investigators are aiming to clarify the timescale and mechanisms contributing to the secondary insults. The investigators also explore usability of novel biomarkers to guide treatment of the patients suffering from SAH.
Detailed description
Subarachnoidal hemorrhage (SAH) is a cause of long-term disability and death. Annually about 1000 people in Finland suffer from SAH, their average age being under 50 years. SAH has a mortality rate of 12 % acutely and 40 % of patients die within a month from admission to hospital. In addition, 30 % of the surviving patients remain with neurological deficits. Most survivors of the primary insult suffer from secondary injury during the first 2-3 weeks from the insult.
Despite the advances in neurosurgical and -radiological techniques and intensive care, the mortality and morbidity rates in SAH have not changed in recent years. There is still only limited understanding of the mechanisms of secondary insults causing brain injury after SAH.
In this study the investigators are aiming to clarify the timescale and mechanisms contributing to the secondary insults. The investigators also explore usability of novel biomarkers to guide treatment of the patients suffering from SAH.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aSAH patients | – | Procedure: Magnetic resonance imaging, Procedure: Cerebral microdialysis catheter insertionPatients suffering from aneurysmal subarachnoid haemorrhage |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients suffering from aneurysmal subarachnoid haemorrhage
Key inclusion criteria (1 listed)
- aneurysmal subarachnoid haemorrhage
Key exclusion criteria (3 listed)
- age under 18 years
- pregnant
- moribund patient
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 |
|---|---|---|
| Magnetic resonance imaging | Procedure or surgery | aSAH patients |
| Cerebral microdialysis catheter insertionIs inserted only when invasive intracranial pressure monitoring is required. The same route with pressure probe is used for insertion. | Procedure or surgery | aSAH patients |
Primary outcome
Neuroradiologically confirmed secondary injury lesions
Time frame: up to 2 weeks after the primary insult
Neuroradiological imaging (CT/MRI) is performed when clinically indicated and at 2 weeks after primary insult.
1 secondary outcome
Neurological outcome of the patient
Time frame: 6 months
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 31 Oct 2017.
Related trials for Aneurysmal Subarachnoid Hemorrhage
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
RecruitingObservational study
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Spontaneous, Subarachnoid Hemorrhage, Aneurysmal
Not yet recruitingPhase 1/2
Induced Suppression of Platelet Activity in Aneurysmal Subarachnoid Hemorrhage Management-2 (iSPASM-2)
Aneurysmal Subarachnoid Hemorrhage
RecruitingPhase 2
Infusion of Lidocaine and Steroids in Middle Meningeal Artery for Pain in Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal, Headache
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aneurysmal Subarachnoid Hemorrhage, run by Tampere University Hospital at 1 site in Finland.
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 3 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 31 Oct 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 Finland. 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?
Neuroradiologically confirmed secondary injury lesions (time frame: up to 2 weeks after the primary insult). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Oct 2017.