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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by Vanderbilt University.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Reid Thompson, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00593268
First received: January 2, 2008
Last updated: June 14, 2013
Last verified: January 2008
  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

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 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)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

18 years of age or older

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00593268

Locations
United States, Tennessee
Vanderbilt University Medical Center, Department of Neurological Surgery
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
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 August 18, 2014