- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00593268
Evaluation of Cerebral Spinal Fluid and Blood in Patients With Subarachnoid Hemorrhage
Biological Markers of Vasospasm in Cerebral Spinal Fluid and Blood in Patients With Subarachnoid Hemorrhage
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center, Department of Neurological Surgery
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
correlate biological markers of cerebral vasospasm with clinical outcomes
Time Frame: post hemorrhage
|
Correlation of blood biological markers and clinical outcomes of cerebral vasospasm
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post hemorrhage
|
Collaborators and Investigators
Investigators
- Principal Investigator: Reid C. Thomspon, M.D., Vanderbilt University Medical Center, Department of Neurological Surgery
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 031084
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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