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

NCT ID: NCT00582868

Last Updated: 2015-10-02

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 10 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-05-31
• Study Completion Date: 2009-05-31

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.

Conditions

Subarachnoid Hemorrhage; Cerebral Vasospasm

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Hemorrhage

Patients having experienced subarachnoid hemorrhage and have in place a ventriculostomy

Licox Brain Oxygen Monitor

Intervention Type: DEVICE

use of data from brain oxygen monitor for analysis

CSF

Intervention Type: OTHER

analysis of CSF for cleaved tau protein

Whole blood

Intervention Type: OTHER

Analysis of whole blood for cleaved-tau protein

Interventions

Licox Brain Oxygen Monitor

use of data from brain oxygen monitor for analysis

Intervention Type: DEVICE

CSF

analysis of CSF for cleaved tau protein

Intervention Type: OTHER

Whole blood

Analysis of whole blood for cleaved-tau protein

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients with subarachnoid hemorrhage
• Patients with external ventricular drains

Exclusion Criteria

• Patients in whom consent is not attainable

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mustafa Baskaya, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin Department of Neurosurgery

Bobby M Agrawal, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin Department of Neurosurgery

Locations

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

H-2006-0421

Identifier Type: -

Identifier Source: org_study_id