Evaluation of Cerebral Spinal Fluid and Blood in Patients With Subarachnoid Hemorrhage

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00593268
First received: January 2, 2008
Last updated: NA
Last verified: January 2008
History: No changes posted

January 2, 2008
January 2, 2008
June 2004
December 2010   (final data collection date for primary outcome measure)
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Not Provided
No Changes Posted
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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

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.

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.

Observational
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Retention:   Samples With DNA
Description:

cerebrospinal fluid and blood

Non-Probability Sample

18 years of age or older

Subarachnoid Hemorrhage
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
150
December 2010
December 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00593268
031084
No
Reid C. Thompson, M.D., Vanderbilt University Medical Center, Department of Neurological Surgery
Vanderbilt University
Not Provided
Principal Investigator: Reid C. Thomspon, M.D. Vanderbilt University Medical Center, Department of Neurological Surgery
Vanderbilt University
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP