Subarachnoid HemorrhageNCT01799018
Role of Proteomics and Metallomics in Cerebral Vasospasm Following Subarachnoid Hemorrhage
An observational study of Subarachnoid Hemorrhage and Cerebral Vasospasm, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
The purpose of this study is to determine the role of Proteomics and Metallomics in Cerebral Vasospasm following Subarachnoid Hemorrhage Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Subarachnoid Hemorrhage, Cerebral Vasospasm, Hydrocephalus
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2011to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to University Hospital.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
State University of New York Upstate Medical University
Syracuse, New York, 13210
About this study
The purpose of this study is to determine the role of Proteomics and Metallomics in Cerebral Vasospasm following Subarachnoid Hemorrhage
- Conditions
- Subarachnoid Hemorrhage, Cerebral Vasospasm, Hydrocephalus
- Keywords
- Xanthine Oxidase, Cerebrospinal fluid
- Medical subject headings
- Subarachnoid Hemorrhage, Vasospasm, Intracranial, Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Protein identification and concentration
Measured: For the duration of CSF drainage, or until the 21st day after admission.
Metal ion identification and concentration
Measured: For the duration of CSF drainage, or until the 21st day after admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startApr 2011
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric M Deshaies, MD, Principal investigator, SUNY Upstate Medical University - Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799018
- Sponsor's protocol ID
- IRB#225490
- Status last verified
- Nov 2014
- First submitted
- 12 Dec 2012
- Last updated
- 20 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Proteomics and Metallomics in Cerebral Vasospasm Following Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT01799018
- Acronym / sponsor ID
- IRB#225490
- Conditions
- Subarachnoid Hemorrhage, Cerebral Vasospasm, Hydrocephalus
- Keywords
- Xanthine Oxidase, Cerebrospinal fluid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 26 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the role of Proteomics and Metallomics in Cerebral Vasospasm following Subarachnoid Hemorrhage
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| 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. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to University Hospital.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Protein identification and concentration
Time frame: For the duration of CSF drainage, or until the 21st day after admission.
Metal ion identification and concentration
Time frame: For the duration of CSF drainage, or until the 21st day after admission.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2014.
Related trials for Subarachnoid Hemorrhage
Not yet recruitingPhase 3
TicAgreLor Versus Placebo to Prevent Cerebral ISCHemia in anEuRysmal Low Grade SAH A Double Blinded Randomised Controlled Study
Subarachnoid Hemorrhage, Aneurysmal, Brain Ischemia
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
RecruitingObservational study
Determining the Clinical Impact and Prevalence of Hemorrhagic Subtypes in Perimesencephalic Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Spontaneous, Subarachnoid Hemorrhage, Aneurysmal
RecruitingObservational study
Smartphone Enabled Detection of Cognitive Motor Dissociation in the ICU
Traumatic Brain Injury (TBI) Patients, Intracerebral Hemorrhage
Not yet recruitingObservational study
Integrating Wearable Monitoring and Clinical Data for Stroke Early Warning
Stroke, Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric M Deshaies, MD principal investigator
SUNY Upstate Medical University - Neurosurgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subarachnoid Hemorrhage and Cerebral Vasospasm, run by State University of New York - Upstate Medical University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Protein identification and concentration (time frame: For the duration of CSF drainage, or until the 21st day after admission.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2014.