Evaluation of Cerebral Spinal Fluid and Blood in Patients With Subarachnoid Hemorrhage
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|ClinicalTrials.gov Identifier: NCT00593268|
Recruitment Status : Active, not recruiting
First Posted : January 14, 2008
Last Update Posted : March 15, 2017
|Condition or disease|
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 :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Biological Markers of Vasospasm in Cerebral Spinal Fluid and Blood in Patients With Subarachnoid Hemorrhage|
|Study Start Date :||June 2004|
|Actual Primary Completion Date :||November 2015|
|Estimated Study Completion Date :||December 2018|
- correlate biological markers of cerebral vasospasm with clinical outcomes [ Time Frame: post hemorrhage ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00593268
|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|