Subarachnoid HemorrhageNCT00593268
Evaluation of Cerebral Spinal Fluid and Blood in Patients With Subarachnoid Hemorrhage
An observational study of Subarachnoid Hemorrhage, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
In this project we are collecting cerebrospinal fluid and blood from patients at Vanderbilt Medical Center who have a subarachnoid hemorrhage which has followed the rupture of a brain aneurysm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: 18 years of age or older
Who may be able to join
- Patients eligible to participate in this study are those that have a documented subarachnoid hemorrhage from a ruptured cerebral aneurysm or patients who have excess cerebrospinal fluid after a Lumbar Puncture or surgery for tumor resection.
- 18 years of age or older
Who cannot join
- Patients or family who are unable to understand the informed consent process will be excluded.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center, Department of Neurological Surgery
Nashville, Tennessee, 37232
About this study
Official title: Biological Markers of Vasospasm in Cerebral Spinal Fluid and Blood in Patients With Subarachnoid Hemorrhage
In this project we are collecting cerebrospinal fluid and blood from patients at Vanderbilt Medical Center who have a subarachnoid hemorrhage which has followed the rupture of a brain aneurysm. We then propose to study the cerebrospinal fluid using a novel microscopic laser directed mass spectrometric analysis (MALDI) available at Vanderbilt. The cerebrospinal fluid and blood will then be analysed for different biological markers, protein expression and gene expression. These markers will then be statistically correlated with clinical data including prediction of vasospasm, time to vasospasm and response to standard therapy.
Read the detailed description
In this project we are collecting cerebrospinal fluid and blood from patients at Vanderbilt Medical Center who have a subarachnoid hemorrhage which has followed the rupture of a brain aneurysm. We then propose to study the cerebrospinal fluid using a novel microscopic laser directed mass spectrometric analysis (MALDI) available at Vanderbilt. The cerebrospinal fluid and blood will then be analysed for different biological markers, protein expression and gene expression. These markers will then be statistically correlated with clinical data including prediction of vasospasm, time to vasospasm and response to standard therapy.
The goal of this study is to determine cerebrospinal fluid and serum markers which will be predictive of vasospasm. This in turn may lead to improved outcomes in this population of patients.
The data will be compared to excess cerebrospinal fluid collected from patients who are undergoing lumbar puncture in the Neurology Clinic or excess cerebrospinal fluid from patients undergoing cranial surgery for other causes like tumor excision.
For patients enrolled in the study, cerebrospinal fluid will be collected by either lumbar puncture or external ventricular catheter. Specimens will be collected immediately pre-operatively if an external ventricular drain is in place or intraoperatively if an external ventricular drain is not present. We will also collect cerebrospinal fluid post operatively after placement of an external ventricular drain regularly from the excess cerebrospinal fluid that has been collected in the drainage bag. CSF will be collected in a serial fashion at multiple time points: immediately post operatively, during vasospasm and before the external ventricular drain is removed.
- Conditions
- Subarachnoid Hemorrhage
- Medical subject headings
- Subarachnoid Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
correlate biological markers of cerebral vasospasm with clinical outcomes
Correlation of blood biological markers and clinical outcomes of cerebral vasospasm
Measured: post hemorrhage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2008 (estimated)
- Study startJun 2004
- Primary completionNov 2015
- Study completionDec 2028 (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.
- More trials run by Vanderbilt University Medical CenterThe 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
- Other
- Time perspective
- Other
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reid Thompson, Vanderbilt University Medical Center
- Investigators
- Reid C. Thomspon, M.D., Principal investigator, Vanderbilt University Medical Center, Department of Neurological Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00593268
- Sponsor's protocol ID
- 031084
- Status last verified
- Mar 2026
- First submitted
- 2 Jan 2008
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Markers of Vasospasm in Cerebral Spinal Fluid and Blood in Patients With Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT00593268
- Acronym / sponsor ID
- 031084
- Conditions
- Subarachnoid Hemorrhage
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- Jun 2004
- Primary completion
- Nov 2015 (actual)
- Study completion
- Dec 2028 (estimated)
- First posted
- 14 Jan 2008 (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.
In this project we are collecting cerebrospinal fluid and blood from patients at Vanderbilt Medical Center who have a subarachnoid hemorrhage which has followed the rupture of a brain aneurysm. We then propose to study the cerebrospinal fluid using a novel microscopic laser directed mass spectrometric analysis (MALDI) available at Vanderbilt. The cerebrospinal fluid and blood will then be analysed for different biological markers, protein expression and gene expression. These markers will then be statistically correlated with clinical data including prediction of vasospasm, time to vasospasm and response to standard therapy.
Detailed description
In this project we are collecting cerebrospinal fluid and blood from patients at Vanderbilt Medical Center who have a subarachnoid hemorrhage which has followed the rupture of a brain aneurysm. We then propose to study the cerebrospinal fluid using a novel microscopic laser directed mass spectrometric analysis (MALDI) available at Vanderbilt. The cerebrospinal fluid and blood will then be analysed for different biological markers, protein expression and gene expression. These markers will then be statistically correlated with clinical data including prediction of vasospasm, time to vasospasm and response to standard therapy.
The goal of this study is to determine cerebrospinal fluid and serum markers which will be predictive of vasospasm. This in turn may lead to improved outcomes in this population of patients.
The data will be compared to excess cerebrospinal fluid collected from patients who are undergoing lumbar puncture in the Neurology Clinic or excess cerebrospinal fluid from patients undergoing cranial surgery for other causes like tumor excision.
For patients enrolled in the study, cerebrospinal fluid will be collected by either lumbar puncture or external ventricular catheter. Specimens will be collected immediately pre-operatively if an external ventricular drain is in place or intraoperatively if an external ventricular drain is not present. We will also collect cerebrospinal fluid post operatively after placement of an external ventricular drain regularly from the excess cerebrospinal fluid that has been collected in the drainage bag. CSF will be collected in a serial fashion at multiple time points: immediately post operatively, during vasospasm and before the external ventricular drain is removed.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 18 years of age or older
Key inclusion criteria (2 listed)
- Patients eligible to participate in this study are those that have a documented subarachnoid hemorrhage from a ruptured cerebral aneurysm or patients who have excess cerebrospinal fluid after a Lumbar Puncture or surgery for tumor resection.
- 18 years of age or older
Key exclusion criteria (1 listed)
- Patients or family who are unable to understand the informed consent process will be excluded.
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
correlate biological markers of cerebral vasospasm with clinical outcomes
Time frame: post hemorrhage
Correlation of blood biological markers and clinical outcomes of cerebral vasospasm
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- 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.
Reid C. Thomspon, M.D. principal investigator
Vanderbilt University Medical Center, Department of Neurological Surgery
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 Vanderbilt University Medical Center at 1 site in United States.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 27 Mar 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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?
correlate biological markers of cerebral vasospasm with clinical outcomes (time frame: post hemorrhage). 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 27 Mar 2026.