- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01799018
Role of Proteomics and Metallomics in Cerebral Vasospasm Following Subarachnoid Hemorrhage
November 19, 2014 updated by: State University of New York - Upstate Medical University
The purpose of this study is to determine the role of Proteomics and Metallomics in Cerebral Vasospasm following Subarachnoid Hemorrhage
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New York
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Syracuse, New York, United States, 13210
- State University of New York Upstate Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 89 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients admitted to University Hospital.
Description
Inclusion Criteria:
- Non traumatic SAH documented by CT scan
- Patient with SAH who would need external ventricular drain (EVD) for the management of hydrocephalus
- Patients with normal pressure Hydrocephalus that require an external drain
- Control (non - hemorrhagic) group - CSF collected from patients with posterior fossa tumor or stroke with EVD in place for the management of hydrocephalus.
Exclusion Criteria:
- Recent infection within last 1 month of presentation- can increase inflammatory markers
- Recent surgery or acute myocardial infarction within last 1 month of presentation
- Age > 89 years or < 18 years
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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SAH Patients
Patients admitted with the diagnosis of aneurismal subarachnoid hemorrhage (SAH) and cerebral angiogram negative SAH who would need to have the external ventricular drain (EVD) placed for the management of hydrocephalus.
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Control Patients
Patients with non-hemorrhagic brain pathology such as posterior fossa tumor or stroke who will have the CSF sampling for diagnostic or therapeutic purposes.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Protein identification and concentration
Time Frame: For the duration of CSF drainage, or until the 21st day after admission.
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For the duration of CSF drainage, or until the 21st day after admission.
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Metal ion identification and concentration
Time Frame: For the duration of CSF drainage, or until the 21st day after admission.
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For the duration of CSF drainage, or until the 21st day after admission.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Eric M Deshaies, MD, SUNY Upstate Medical University - Neurosurgery
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
December 12, 2012
First Submitted That Met QC Criteria
February 22, 2013
First Posted (Estimate)
February 26, 2013
Study Record Updates
Last Update Posted (Estimate)
November 20, 2014
Last Update Submitted That Met QC Criteria
November 19, 2014
Last Verified
November 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB#225490
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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