NCT00582868

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2007

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2007

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 28, 2007

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

October 2, 2015

Status Verified

April 1, 2012

First QC Date

December 19, 2007

Last Update Submit

October 1, 2015

Conditions

Subarachnoid HemorrhageCerebral Vasospasm

Keywords

Subarachnoid hemorrhageCerebral VasospasmCleaved-tau proteinBrain oxygen tension level

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Clinical outcome score correlated to changes in brain oxygen tension level, cerebral blood flow, and cleaved tau protein levels

    Three months after subarachnoid hemorrhage

Study Arms (1)

Hemorrhage

Patients having experienced subarachnoid hemorrhage and have in place a ventriculostomy

Device: Licox Brain Oxygen MonitorOther: CSFOther: Whole blood

Interventions

Licox Brain Oxygen MonitorDEVICE

use of data from brain oxygen monitor for analysis

Hemorrhage
CSFOTHER

analysis of CSF for cleaved tau protein

Hemorrhage
Whole bloodOTHER

Analysis of whole blood for cleaved-tau protein

Hemorrhage

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with subarachnoid hemorrhage

You may qualify if:

  • Patients with subarachnoid hemorrhage
  • Patients with external ventricular drains

You may not qualify if:

  • Patients in whom consent is not attainable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Cerebrospinal fluid Whole blood

MeSH Terms

Conditions

Subarachnoid HemorrhageVasospasm, Intracranial

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mustafa Baskaya, MD

    University of Wisconsin Department of Neurosurgery

    PRINCIPAL INVESTIGATOR

  • Bobby M Agrawal, MD

    University of Wisconsin Department of Neurosurgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2007

First Posted

December 28, 2007

Study Start

May 1, 2007

Study Completion

May 1, 2009

Last Updated

October 2, 2015

Record last verified: 2012-04

Locations

US(1)