Evaluation of Cerebral Spinal Fluid and Blood in Patients With Subarachnoid Hemorrhage
| Tracking Information | |||||
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| First Received Date ICMJE | January 2, 2008 | ||||
| Last Updated Date | January 2, 2008 | ||||
| Start Date ICMJE | June 2004 | ||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluation of Cerebral Spinal Fluid and Blood in Patients With Subarachnoid Hemorrhage | ||||
| Official Title ICMJE | Biological Markers of Vasospasm in Cerebral Spinal Fluid and Blood in Patients With Subarachnoid Hemorrhage | ||||
| Brief 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. 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Not Provided | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: cerebrospinal fluid and blood |
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| Sampling Method | Non-Probability Sample | ||||
| Study Population | 18 years of age or older |
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| Condition ICMJE | Subarachnoid Hemorrhage | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||
| Estimated Enrollment ICMJE | 150 | ||||
| Estimated Completion Date | December 2010 | ||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00593268 | ||||
| Other Study ID Numbers ICMJE | 031084 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Reid C. Thompson, M.D., Vanderbilt University Medical Center, Department of Neurological Surgery | ||||
| Study Sponsor ICMJE | Vanderbilt University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Vanderbilt University | ||||
| Verification Date | January 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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