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

Terminated

• Conditions: Subarachnoid Hemorrhage; Cerebral Vasospasm
• Interventions: Device: Licox Brain Oxygen Monitor; Other: CSF; Other: Whole blood

• Registration Number: NCT00582868
• Lead Sponsor: University of Wisconsin, Madison

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 Timeline

• Study Start: 2007-05
• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-19
• Study First Posted: 2007-12-28
• Study Completion: 2009-05
• Status Verified: 2012-04
• Last Update Submitted: 2015-10-01
• Last Update Posted: 2015-10-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Patients with subarachnoid hemorrhage
• Patients with external ventricular drains

Exclusion Criteria

• Patients in whom consent is not attainable

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hemorrhage	Licox Brain Oxygen Monitor	Patients having experienced subarachnoid hemorrhage and have in place a ventriculostomy
Hemorrhage	CSF	Patients having experienced subarachnoid hemorrhage and have in place a ventriculostomy
Hemorrhage	Whole blood	Patients having experienced subarachnoid hemorrhage and have in place a ventriculostomy

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Clinical outcome score correlated to changes in brain oxygen tension level, cerebral blood flow, and cleaved tau protein levels	Three months after subarachnoid hemorrhage

Trial Locations

Locations (1)

University of Wisconsin Hospital and Clinics; 🇺🇸 Madison, Wisconsin, United States