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

Subarachnoid Hemorrhage Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00582868
• Other study ID #: H-2006-0421
• Status: Terminated
• Phase: N/A
• First received: December 19, 2007
• Last updated: October 1, 2015
• Start date: May 2007
• Est. completion date: May 2009

Study information

• Verified date: April 2012
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with subarachnoid hemorrhage

• Patients with external ventricular drains

Exclusion Criteria:

• Patients in whom consent is not attainable

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cerebral Vasospasm
• Hemorrhage
• Subarachnoid Hemorrhage
• Vasospasm, Intracranial

Intervention

Device:
• Licox Brain Oxygen Monitor
use of data from brain oxygen monitor for analysis

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

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in brain oxygen tension level, cerebral blood flow, and cleaved tau protein levels in correlation to cerebral vasospasm		The first 14 days after subarachnoid hemorrhage	No
Secondary	Clinical outcome score correlated to changes in brain oxygen tension level, cerebral blood flow, and cleaved tau protein levels		Three months after subarachnoid hemorrhage	No