Subarachnoid HemorrhageNCT02334657
Prospective Study of Long-term Outcome After Non-aneurysmal Subarachnoid Hemorrhage
An observational study of Subarachnoid Hemorrhage, run by University Clinic Frankfurt.
Trial summary
Spontaneous subarachnoid hemorrhage (SAH) is usually caused by rupture of an intracranial aneurysm, but in up to 15% of patients with spontaneous SAH, no discernible bleeding source can be identified despite of repetitive radiological imaging. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Subarachnoid Hemorrhage
- What is being tested?
- SF-36
- How many people
- 173 participants
- Where
- No sites listed yet
- Study dates
- Nov 2013to Jan 2015
- How long will I take part?
- 15 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with a spontaneous, non-traumatic SAH, in whom no bleeding source was identified by repetitive angiography including 3D digital subtraction angiography
Who may be able to join
- spontaneous, non-traumatic SAH
- SAH confirmed on computed tomography (CT) or lumbar puncture
- negative initial and follow-up angiography
- age: no limit
Who cannot join
- traumatic SAH
- aneurysmal SAH
- SAH in whom other bleeding sources were identified (AVM etc.)
About this study
Spontaneous subarachnoid hemorrhage (SAH) is usually caused by rupture of an intracranial aneurysm, but in up to 15% of patients with spontaneous SAH, no discernible bleeding source can be identified despite of repetitive radiological imaging. Patients, at least 18 months after ictus of a non-aneurysmal SAH, received a regular mail including a letter explaining the study purpose and the postal questionnaire consisting a short-form health survey with 36 simple questions. If we didn't receive answers after three months we made telephone interviews with the patients' family members or their general practitioner.
Read the detailed description
Spontaneous subarachnoid hemorrhage (SAH) is usually caused by rupture of an intracranial aneurysm, but in up to 15% of patients with spontaneous SAH, no discernible bleeding source can be identified despite of repetitive radiological imaging. The blood distribution can be described as perimesencephalic/prepontine or non-perimesencephalic. Depending on the pattern of SAH the clinical course of the patients can be similar to aneurysmal SAH. In general, patients with a perimesencephalic SAH (PM-SAH) are considered to achieve good outcome and to have lower rebleeding risk. However, long-term outcome data on patients suffering from spontaneous non-aneurysmal SAH (non-aSAH) is scarce and lacking for physical and psychological outcome. Therefore, the aim of the present study was to investigate the long-term physical and psychological outcome in patients suffering from non-aneurysmal spontaneous SAH.
SAH was confirmed on computed tomography (CT) or lumbar puncture. Only patients with a non-traumatic SAH were included. In our hospital algorithm all patients with SAH underwent angiography including 3D digital subtraction angiography (DSA) since 2002 to rule out intracranial sources for SAH. In case of a negative initial angiography, DSA was repeated after 14 days. Additionally, magnetic resonance imaging (MRI) of head/spine was performed to rule out any spinal bleeding sources. In patients with blood distribution exceeding the typical perimesencephalic pattern, a third DSA was performed 3 months after SAH. The first (short-term) follow-up (F/U) was performed six months after ictus. Outcome was measured according to the modified Rankin Scale (mRS) and stratified into favorable (mRS 0-2) and unfavorable (mRS 3-6) after six months. Patients with non-aSAH were divided into perimesencephalic SAH (PM-SAH), non-perimesencephalic SAH (NPM-SAH) and excellent Outcome group (mRS 0). Also the NPM-SAH group was further stratified into Fisher 3 blood pattern and NPM-SAH without Fisher 3 blood pattern.
Patients, at least 18 months after ictus of a non-aneurysmal SAH, received a regular mail including a letter explaining the study purpose and the postal questionnaire consisting a short-form health survey with 36 simple questions. If we didn't receive answers after three months we made telephone interviews with the patients' family members or their general practitioner.
- Conditions
- Subarachnoid Hemorrhage
- Being tested
- SF-36
- Keywords
- non-aneurysmal
- Medical subject headings
- Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SF-36Other
postal questionnaire consisting a short-form health survey with 36 simple questions (SF-36)
| Study group | Role | What they receive |
|---|---|---|
| non-aneurysmal subarachnoid hemorrhage | patients with non-aneurysmal subarachnoid hemorrhage, short-term outcome measured by modified Rankin Scale and long-term outcome by SF-36 Receives: Other: SF-36 | |
| perimesencephalic SAH | subgroup of non-aneurysmal subarachnoid hemorrhage Receives: Other: SF-36 | |
| non-perimesencephalic (NPM) SAH | subgroup of non-aneurysmal subarachnoid hemorrhage Receives: Other: SF-36 | |
| subgroup of NPM-SAH with Fisher 3 | patients with non-aneurysmal (non-perimesencephalic) SAH and a Fisher 3 bleeding pattern Receives: Other: SF-36 | |
| subgroup of NPM-SAH w/o Fisher 3 | patients with non-aneurysmal (non-perimesencephalic) SAH and not a Fisher 3 bleeding pattern Receives: Other: SF-36 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Long-term outcome of all patients after non-aneurysmal SAH compared to standard population, measured by SF-36
Long-term outcome of all patients after non-aneurysmal SAH compared to standard population, measured by SF-36 stratified to:
- non-aneurysmal SAH
- PM /NPM-SAH
- mRS 0 group
- NPM-SAH: Fisher 3 or non-Fisher 3 bleeding pattern
Measured: 18months to 15 years
Secondary outcomes (1)
mortality
deaths until long-term follow-up
Measured: 18months to 15 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2015 (estimated)
- Study startNov 2013
- Primary completionSep 2014
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- 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
- 173 participants (actual)
- Target duration
- 15 Years
Sponsor and investigators
- Lead sponsor
- University Clinic Frankfurt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juergen Konczalla, University Clinic Frankfurt
- Investigators
- Juergen Konczalla, MD, Principal investigator, Goethe University Hospital, Department of Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02334657
- Sponsor's protocol ID
- 109/13
- Status last verified
- May 2016
- First submitted
- 6 Jan 2015
- Last updated
- 4 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Konczalla J, Schmitz J, Kashefiolasl S, Senft C, Platz J, Seifert V. Non-aneurysmal non-perimesencephalic subarachnoid hemorrhage: effect of rehabilitation at short-term and in a prospective study of long-term follow-up. Top Stroke Rehabil. 2016 Aug;23(4):261-8. doi: 10.1080/10749357.2016.1149982. Epub 2016 Mar 15.
PubMed 26916565Konczalla J, Schmitz J, Kashefiolasl S, Senft C, Seifert V, Platz J. Non-aneurysmal subarachnoid hemorrhage in 173 patients: a prospective study of long-term outcome. Eur J Neurol. 2015 Oct;22(10):1329-36. doi: 10.1111/ene.12762. Epub 2015 Jul 1.
PubMed 26130053
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Long-term Outcome After Non-aneurysmal Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT02334657
- Acronym / sponsor ID
- 109/13
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- non-aneurysmal
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- University Clinic FrankfurtUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 8 Jan 2015 (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.
Spontaneous subarachnoid hemorrhage (SAH) is usually caused by rupture of an intracranial aneurysm, but in up to 15% of patients with spontaneous SAH, no discernible bleeding source can be identified despite of repetitive radiological imaging. Patients, at least 18 months after ictus of a non-aneurysmal SAH, received a regular mail including a letter explaining the study purpose and the postal questionnaire consisting a short-form health survey with 36 simple questions. If we didn't receive answers after three months we made telephone interviews with the patients' family members or their general practitioner.
Detailed description
Spontaneous subarachnoid hemorrhage (SAH) is usually caused by rupture of an intracranial aneurysm, but in up to 15% of patients with spontaneous SAH, no discernible bleeding source can be identified despite of repetitive radiological imaging. The blood distribution can be described as perimesencephalic/prepontine or non-perimesencephalic. Depending on the pattern of SAH the clinical course of the patients can be similar to aneurysmal SAH. In general, patients with a perimesencephalic SAH (PM-SAH) are considered to achieve good outcome and to have lower rebleeding risk. However, long-term outcome data on patients suffering from spontaneous non-aneurysmal SAH (non-aSAH) is scarce and lacking for physical and psychological outcome. Therefore, the aim of the present study was to investigate the long-term physical and psychological outcome in patients suffering from non-aneurysmal spontaneous SAH.
SAH was confirmed on computed tomography (CT) or lumbar puncture. Only patients with a non-traumatic SAH were included. In our hospital algorithm all patients with SAH underwent angiography including 3D digital subtraction angiography (DSA) since 2002 to rule out intracranial sources for SAH. In case of a negative initial angiography, DSA was repeated after 14 days. Additionally, magnetic resonance imaging (MRI) of head/spine was performed to rule out any spinal bleeding sources. In patients with blood distribution exceeding the typical perimesencephalic pattern, a third DSA was performed 3 months after SAH. The first (short-term) follow-up (F/U) was performed six months after ictus. Outcome was measured according to the modified Rankin Scale (mRS) and stratified into favorable (mRS 0-2) and unfavorable (mRS 3-6) after six months. Patients with non-aSAH were divided into perimesencephalic SAH (PM-SAH), non-perimesencephalic SAH (NPM-SAH) and excellent Outcome group (mRS 0). Also the NPM-SAH group was further stratified into Fisher 3 blood pattern and NPM-SAH without Fisher 3 blood pattern.
Patients, at least 18 months after ictus of a non-aneurysmal SAH, received a regular mail including a letter explaining the study purpose and the postal questionnaire consisting a short-form health survey with 36 simple questions. If we didn't receive answers after three months we made telephone interviews with the patients' family members or their general practitioner.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 15 Years
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| non-aneurysmal subarachnoid hemorrhage | – | Other: SF-36patients with non-aneurysmal subarachnoid hemorrhage, short-term outcome measured by modified Rankin Scale and long-term outcome by SF-36 |
| perimesencephalic SAH | – | Other: SF-36subgroup of non-aneurysmal subarachnoid hemorrhage |
| non-perimesencephalic (NPM) SAH | – | Other: SF-36subgroup of non-aneurysmal subarachnoid hemorrhage |
| subgroup of NPM-SAH with Fisher 3 | – | Other: SF-36patients with non-aneurysmal (non-perimesencephalic) SAH and a Fisher 3 bleeding pattern |
| subgroup of NPM-SAH w/o Fisher 3 | – | Other: SF-36patients with non-aneurysmal (non-perimesencephalic) SAH and not a Fisher 3 bleeding pattern |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with a spontaneous, non-traumatic SAH, in whom no bleeding source was identified by repetitive angiography including 3D digital subtraction angiography
Key inclusion criteria (4 listed)
- spontaneous, non-traumatic SAH
- SAH confirmed on computed tomography (CT) or lumbar puncture
- negative initial and follow-up angiography
- age: no limit
Key exclusion criteria (3 listed)
- traumatic SAH
- aneurysmal SAH
- SAH in whom other bleeding sources were identified (AVM etc.)
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 |
|---|---|---|
| SF-36postal questionnaire consisting a short-form health survey with 36 simple questions (SF-36) | Other | non-aneurysmal subarachnoid hemorrhage, non-perimesencephalic (NPM) SAH, perimesencephalic SAH, subgroup of NPM-SAH w/o Fisher 3, subgroup of NPM-SAH with Fisher 3 |
Primary outcome
Long-term outcome of all patients after non-aneurysmal SAH compared to standard population, measured by SF-36
Time frame: 18months to 15 years
Long-term outcome of all patients after non-aneurysmal SAH compared to standard population, measured by SF-36 stratified to: * non-aneurysmal SAH * PM /NPM-SAH * mRS 0 group * NPM-SAH: Fisher 3 or non-Fisher 3 bleeding pattern
1 secondary outcome
mortality
Time frame: 18months to 15 years
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 4 May 2016.
- Derived from this study: PubMed 26916565Konczalla J, Schmitz J, Kashefiolasl S, Senft C, Platz J, Seifert V. Non-aneurysmal non-perimesencephalic subarachnoid hemorrhage: effect of rehabilitation at short-term and in a prospective study of long-term follow-up. Top Stroke Rehabil. 2016 Aug;23(4):261-8. doi: 10.1080/10749357.2016.1149982. Epub 2016 Mar 15.
- Derived from this study: PubMed 26130053Konczalla J, Schmitz J, Kashefiolasl S, Senft C, Seifert V, Platz J. Non-aneurysmal subarachnoid hemorrhage in 173 patients: a prospective study of long-term outcome. Eur J Neurol. 2015 Oct;22(10):1329-36. doi: 10.1111/ene.12762. Epub 2015 Jul 1.
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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.
Juergen Konczalla, MD principal investigator
Goethe University Hospital, Department of Neurosurgery
Questions about this trial
What is this clinical trial studying?
An observational study of Subarachnoid Hemorrhage, run by University Clinic Frankfurt.
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 4 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 4 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Long-term outcome of all patients after non-aneurysmal SAH compared to standard population, measured by SF-36 (time frame: 18months to 15 years). 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 NCT02334657, which also lists 2 linked publications.
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 4 May 2016.