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Use of Brain Oxygen Tension Level and Cleaved-tau Protein to Detect Vasospasm After SAH

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ClinicalTrials.gov Identifier: NCT00582868
Recruitment Status : Terminated (Insufficient subject enrollment)
First Posted : December 28, 2007
Last Update Posted : October 2, 2015
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Description
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Brief Summary:
The purpose of this study is to investigate if brain oxygen levels, levels of a specific protein in the cerebrospinal fluid and blood (Cleaved-tau protein), and brain blood flow can predict spasm of brain blood vessels after bleeding in the brain from a ruptured aneurysm.

Condition or disease Intervention/treatment
Subarachnoid Hemorrhage Cerebral Vasospasm Device: Licox Brain Oxygen Monitor Other: CSF Other: Whole blood

Detailed Description:

Rupture of a cerebral aneurysm causes subarachnoid hemorrhage (SAH). Blood in the subarachnoid space of the brain can cause irritation of the cerebral blood vessels, leading to constriction of these vessels, a phenomenon known.as vasospasm. Cerebral vasospasm can cause stroke and possibly death. Of all the patients with SAH, approximately 20-40% will suffer from clinical vasospasm and more than 60% of those patients will never get back to their previous functional status. Tools to identify early vasospasm and thus early treatment could greatly decrease the morbidity and mortality following SAH.

Cleaved tau protein is a neuronal marker that has been detected in blood and CSF of stroke patients early in its time course. Since vasospasm can lead to stroke, the purpose of this project is to determine whether increase in cleaved tau protein in blood and/or CSF can predict early stroke from vasospasm. Changes in brain oxygen tension measured by a brain tissue oxygen monitor and cerebral blood flow measured by CT perfusion will be correlated with cleaved tau protein levels and clinical status. Utilizing statistical analysis the levels of Cleaved tau protein, brain oxygen and blood flow during hospitalization will be correlated with patient outcome. Through this study we hope to identify increase in cleaved tau protein and decrease in cerebral blood flow and oxygenation as predictors of early vasospasm. Early detection and treatment of vasospasm could decrease the stroke rate in SAH patients and therefore be of great benefit to society.

Study Design
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Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Brain Oxygen Tension Level, Cerebral Perfusion and Cleaved-tau Protein for Detection of Cerebral Vasospasm and Independent Predictor of Poor Outcome After Aneurysmal Subarachnoid Hemorrhage
Study Start Date : May 2007
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Hemorrhage
Patients having experienced subarachnoid hemorrhage and have in place a ventriculostomy
 Device: Licox Brain Oxygen Monitor
use of data from brain oxygen monitor for analysis

Other: CSF
analysis of CSF for cleaved tau protein

Other: Whole blood
Analysis of whole blood for cleaved-tau protein


Outcome Measures
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Primary Outcome Measures :
  1. Changes in brain oxygen tension level, cerebral blood flow, and cleaved tau protein levels in correlation to cerebral vasospasm [ Time Frame: The first 14 days after subarachnoid hemorrhage ]

Secondary Outcome Measures :
  1. Clinical outcome score correlated to changes in brain oxygen tension level, cerebral blood flow, and cleaved tau protein levels [ Time Frame: Three months after subarachnoid hemorrhage ]

Biospecimen Retention:   Samples With DNA
Cerebrospinal fluid Whole blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with subarachnoid hemorrhage
Criteria

Inclusion Criteria:

  • Patients with subarachnoid hemorrhage
  • Patients with external ventricular drains

Exclusion Criteria:

  • Patients in whom consent is not attainable
Contacts and Locations
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Information from the National Library of Medicine

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): NCT00582868


Locations
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United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Mustafa Baskaya, MD University of Wisconsin Department of Neurosurgery
Principal Investigator: Bobby M Agrawal, MD University of Wisconsin Department of Neurosurgery
More Information
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00582868    
Other Study ID Numbers: H-2006-0421
First Posted: December 28, 2007    Key Record Dates
Last Update Posted: October 2, 2015
Last Verified: April 2012
Keywords provided by University of Wisconsin, Madison:
Subarachnoid hemorrhage
Cerebral Vasospasm
Cleaved-tau protein
Brain oxygen tension level
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Vasospasm, Intracranial
Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
 Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases