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

• ClinicalTrials.gov Identifier: NCT00582868
• Recruitment Status: Terminated
• First Posted: December 28, 2007
• Last Update Posted: October 2, 2015
• Sponsor: University of Wisconsin, Madison
• 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
• 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

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

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
• Current Responsible Party: University of Wisconsin, Madison
• Original Responsible Party: Dr. Mustafa Baskaya, MD, University of Wisconsin-Department of Neurosurgery
• Current Study Sponsor: University of Wisconsin, Madison
• Original Study Sponsor: Same as current
• 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