Clinical trial NCT00593268: Evaluation of Cerebral Spinal Fluid and Blood in Patients With Subarachnoid Hemorrhage
Official title: Biological Markers of Vasospasm in Cerebral Spinal Fluid and Blood in Patients With Subarachnoid Hemorrhage
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Subarachnoid Hemorrhage
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2008-01-14
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18 years of age or older

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: correlate biological markers of cerebral vasospasm with clinical outcomes
timeFrame: post hemorrhage
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center, Department of Neurological Surgery
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center, Department of Neurological Surgery
name: Reid C. Thomspon, M.D.
role: PRINCIPAL_INVESTIGATOR
References: