Clinical trial NCT00582868: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Subarachnoid Hemorrhage
Cerebral Vasospasm
Keywords: Subarachnoid hemorrhage
Cerebral Vasospasm
Cleaved-tau protein
Brain oxygen tension level
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2007-12-28
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with 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.

Eligibility criteria: Inclusion Criteria:

* Patients with subarachnoid hemorrhage
* Patients with external ventricular drains

Exclusion Criteria:

* Patients in whom consent is not attainable

Primary outcomes:
measure: Changes in brain oxygen tension level, cerebral blood flow, and cleaved tau protein levels in correlation to cerebral vasospasm
timeFrame: The first 14 days after subarachnoid hemorrhage
Secondary outcomes:
measure: Clinical outcome score correlated to changes in brain oxygen tension level, cerebral blood flow, and cleaved tau protein levels
timeFrame: Three months after subarachnoid hemorrhage
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
Study officials:
affiliation: University of Wisconsin Department of Neurosurgery
name: Mustafa Baskaya, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Wisconsin Department of Neurosurgery
name: Bobby M Agrawal, MD
role: PRINCIPAL_INVESTIGATOR
References: