Subarachnoid HemorrhageNCT01292278
Constitution of Cerebrospinal Fluid and Blood Database/Specimen in Acute Stage of Subarachnoid Hemorrhage (aSAH) Patients
An observational study of Subarachnoid Hemorrhage, run by University of Regensburg at 1 site in Germany.
Trial summary
Neuropeptide Y (NPY) may play a major role in the pathophysiology of aneurysmal subarachnoid hemorrhage (aSAH). To investigate the correlation of NPY in cerebrospinal fluid (CSF) and blood (serum) and the neurological outcome in the acute stage of aSAH. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Subarachnoid Hemorrhage
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2006to Dec 2016
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: consecutive pts. with subarachnoid hemorrhage
Who may be able to join
- spontaneous or aneurysmal subarachnoid hemorrhage
Who cannot join
- age younger than 18 years or older than 70 years
- inflammatory disease
- history of former SAH
- no ventricular drainage
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Neurosurgery Medical Center University of Regensburg
Regensburg, 93053
Karl-Michael Schebesch, M.D., ++49 +941 944 9010, karl-michael.schebesch@klinik.uni-regensburg.de
Karl-Michael Schebesch, M.D.
About this study
Official title: The Possible Role of Neuropeptide Y After Spontaneous Subarachnoid Hemorrhage
Neuropeptide Y (NPY) may play a major role in the pathophysiology of aneurysmal subarachnoid hemorrhage (aSAH). To investigate the correlation of NPY in cerebrospinal fluid (CSF) and blood (serum) and the neurological outcome in the acute stage of aSAH.
Read the detailed description
Evaluation of Neuropeptides in CSF and serum in SAH patients
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- subarachnoid hemorrhage, cerebral vasospasm, neuropeptide Y, spontaneous, aneurysmal
- Medical subject headings
- Subarachnoid Hemorrhage, Vasospasm, Intracranial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| aSAH | consecutive patients with spontaneous or aneurysmal subarachnoid hemorrhage | |
| control group | no neurological disease but spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glasgow Outcome Scale
Measured: 2011-2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startJan 2006
- Primary completionAug 2015 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Regensburg
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Munich
- Responsible party
- Principal investigator, Karl-Michael Schebesch, University of Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292278
- Sponsor's protocol ID
- CSF 06/179
- Status last verified
- Dec 2014
- First submitted
- 8 Feb 2011
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Possible Role of Neuropeptide Y After Spontaneous Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT01292278
- Acronym / sponsor ID
- CSF 06/179
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- subarachnoid hemorrhage, cerebral vasospasm, neuropeptide Y, spontaneous, aneurysmal
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Collaborators
- Technical University of Munich
- Study start
- Jan 2006
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 9 Feb 2011 (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.
Neuropeptide Y (NPY) may play a major role in the pathophysiology of aneurysmal subarachnoid hemorrhage (aSAH). To investigate the correlation of NPY in cerebrospinal fluid (CSF) and blood (serum) and the neurological outcome in the acute stage of aSAH.
Detailed description
Evaluation of Neuropeptides in CSF and serum in SAH patients
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| aSAH | – | –consecutive patients with spontaneous or aneurysmal subarachnoid hemorrhage |
| control group | – | –no neurological disease but spinal anesthesia |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive pts. with subarachnoid hemorrhage
Key inclusion criteria (1 listed)
- spontaneous or aneurysmal subarachnoid hemorrhage
Key exclusion criteria (4 listed)
- age younger than 18 years or older than 70 years
- inflammatory disease
- history of former SAH
- no ventricular drainage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Glasgow Outcome Scale
Time frame: 2011-2016
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2014.
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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.
Department of Neurosurgery Medical Center University of Regensburg
Regensburg, Germany
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 Subarachnoid Hemorrhage, run by University of Regensburg at 1 site in Germany.
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 4 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: status not confirmed, as of the sponsor's last update on 5 Dec 2014. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgow Outcome Scale (time frame: 2011-2016). 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 5 Dec 2014.