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

This study has been terminated.
(Insufficient subject enrollment)
Sponsor:
Information provided by (Responsible Party):
Bobby Agrawal, University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00582868
First received: December 19, 2007
Last updated: April 25, 2012
Last verified: April 2012
  Purpose

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 Intervention
Subarachnoid Hemorrhage
Cerebral Vasospasm
Device: Licox Brain Oxygen Monitor
Other: CSF
Other: Whole blood

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Cerebrospinal fluid Whole blood


Enrollment: 10
Study Start Date: May 2007
Study Completion Date: May 2009
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
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: NCT00582868

Locations
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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

No publications provided

Responsible Party: Bobby Agrawal, Resident, University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00582868     History of Changes
Other Study ID Numbers: H-2006-0421
Study First Received: December 19, 2007
Last Updated: April 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Subarachnoid hemorrhage
Cerebral Vasospasm
Cleaved-tau protein
Brain oxygen tension level

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Vasospasm, Intracranial
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