Evaluation of Cerebral Spinal Fluid and Blood in Patients With Subarachnoid Hemorrhage
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Purpose
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.
| Condition |
|---|
|
Subarachnoid Hemorrhage |
| Study Type: | Observational |
| Official Title: | Biological Markers of Vasospasm in Cerebral Spinal Fluid and Blood in Patients With Subarachnoid Hemorrhage |
- correlate biological markers of cerebral vasospasm with clinical outcomes [ Time Frame: post hemorrhage ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
cerebrospinal fluid and blood
| Estimated Enrollment: | 150 |
| Study Start Date: | June 2004 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
18 years of age or older
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients or family who are unable to understand the informed consent process will be excluded.
Contacts and Locations| United States, Tennessee | |
| Vanderbilt University Medical Center, Department of Neurological Surgery | |
| Nashville, Tennessee, United States, 37232 | |
| Principal Investigator: | Reid C. Thomspon, M.D. | Vanderbilt University Medical Center, Department of Neurological Surgery |
More Information
No publications provided
| Responsible Party: | Reid Thompson, Professor of Neurological Surgery, Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00593268 History of Changes |
| Other Study ID Numbers: | 031084 |
| Study First Received: | January 2, 2008 |
| Last Updated: | June 14, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Hemorrhage Subarachnoid Hemorrhage Pathologic Processes Intracranial Hemorrhages Cerebrovascular Disorders |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on June 18, 2013