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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

Tracking Information
First Submitted Date December 19, 2007
First Posted Date December 28, 2007
Last Update Posted Date October 2, 2015
Study Start Date May 2007
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: December 19, 2007)
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 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00582868 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 19, 2007)
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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Use of Brain Oxygen Tension Level and Cleaved-tau Protein to Detect Vasospasm After SAH
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
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.
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Cerebrospinal fluid Whole blood
Sampling Method Non-Probability Sample
Study Population Patients with subarachnoid hemorrhage
Condition
  • Subarachnoid Hemorrhage
  • Cerebral Vasospasm
Intervention
  • 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
Study Groups/Cohorts Hemorrhage
Patients having experienced subarachnoid hemorrhage and have in place a ventriculostomy
Interventions:
  • Device: Licox Brain Oxygen Monitor
  • Other: CSF
  • Other: Whole blood
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: April 25, 2012)
10
Original Estimated Enrollment
 (submitted: December 19, 2007)
100
Actual Study Completion Date May 2009
Primary Completion Date Not Provided
Eligibility Criteria

Inclusion Criteria:

  • Patients with subarachnoid hemorrhage
  • Patients with external ventricular drains

Exclusion Criteria:

  • Patients in whom consent is not attainable
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00582868
Other Study ID Numbers H-2006-0421
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Wisconsin, Madison
Study Sponsor University of Wisconsin, Madison
Collaborators Not Provided
Investigators
Principal Investigator: Mustafa Baskaya, MD University of Wisconsin Department of Neurosurgery
Principal Investigator: Bobby M Agrawal, MD University of Wisconsin Department of Neurosurgery
PRS Account University of Wisconsin, Madison
Verification Date April 2012