Subarachnoid HemorrhageVISION 2NCT01169454
Ventriculostomy in Subarachnoid Hemorrhage (SAH): Intracranial Pressure (ICP) Open or Not?
An observational study of Subarachnoid Hemorrhage, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to explore two currently accepted methods of intracranial pressure (ICP) management through cerebral spinal fluid (CRF) drainage for patients diagnosed with subarachnoid hemorrhage (SAH). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Sep 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with subarachnoid hemorrhage
Who may be able to join
- Admitted to Duke University NCCU
- Adult (18 years of age or older)
- Primary diagnosis is Subarachnoid Hemorrhage
- Intraventricular catheter in situ
Who cannot join
- Glasgow Coma Score = 3
- Hunt and Hess Score = 5
- Prisoners
- Ventriculostomy > 72 hours
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: Ventriculostomy in SAH: ICP Open or Not?
The purpose of this study is to explore two currently accepted methods of intracranial pressure (ICP) management through cerebral spinal fluid (CRF) drainage for patients diagnosed with subarachnoid hemorrhage (SAH). This is a randomized observational study of two physician-prescribed approaches to managing ICP monitoring and CSF drainage for SAH patients. The study will enroll only those patients who have ICP monitoring. Because this is an observational study, there are no physical risks to the patient, the only risk is loss of confidentiality.
Read the detailed description
Patients diagnosed with subarachnoid hemorrhage (SAH) who require intracranial pressure (ICP) management through cerebral spinal fluid (CRF) drainage will be eligible for this study.
Subjects will be randomized to receive one of two currently accepted methods of ICP management. The first is ICP monitoring with intermittent CSF drainage and the second is through continuous CSF drainage at set pressure thresholds.
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- Cerebral Spinal Fluid, Ventriculostomy, Subarachnoid hemorrhage, Vasospasm, Human Subjects
- Medical subject headings
- Subarachnoid Hemorrhage
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 |
|---|---|---|
| Monitor then drain | Subjects who are treated with intermittent CSF drainage | |
| Drain then monitor | Subjects who are treated with continuous CSF drainage at set pressure thresholds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral artery vasospasm
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2010 (estimated)
- Study startMar 2009
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Sponsor
- Investigators
- DaiWai M Olson, PhD RN CCRN, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01169454
- Sponsor's protocol ID
- Pro00016054
- Acronym
- VISION 2
- Status last verified
- Apr 2015
- First submitted
- 22 Jul 2010
- Last updated
- 6 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Olson DM, Zomorodi M, Britz GW, Zomorodi AR, Amato A, Graffagnino C. Continuous cerebral spinal fluid drainage associated with complications in patients admitted with subarachnoid hemorrhage. J Neurosurg. 2013 Oct;119(4):974-80. doi: 10.3171/2013.6.JNS122403. Epub 2013 Aug 20.
PubMed 23957382
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventriculostomy in SAH: ICP Open or Not?
- ClinicalTrials.gov ID
- NCT01169454
- Acronym / sponsor ID
- VISION 2 / Pro00016054
- Conditions
- Subarachnoid Hemorrhage
- Keywords
- Cerebral Spinal Fluid, Ventriculostomy, Subarachnoid hemorrhage, Vasospasm, Human Subjects
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- Mar 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 26 Jul 2010 (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 explore two currently accepted methods of intracranial pressure (ICP) management through cerebral spinal fluid (CRF) drainage for patients diagnosed with subarachnoid hemorrhage (SAH). This is a randomized observational study of two physician-prescribed approaches to managing ICP monitoring and CSF drainage for SAH patients. The study will enroll only those patients who have ICP monitoring. Because this is an observational study, there are no physical risks to the patient, the only risk is loss of confidentiality.
Detailed description
Patients diagnosed with subarachnoid hemorrhage (SAH) who require intracranial pressure (ICP) management through cerebral spinal fluid (CRF) drainage will be eligible for this study.
Subjects will be randomized to receive one of two currently accepted methods of ICP management. The first is ICP monitoring with intermittent CSF drainage and the second is through continuous CSF drainage at set pressure thresholds.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monitor then drain | – | –Subjects who are treated with intermittent CSF drainage |
| Drain then monitor | – | –Subjects who are treated with continuous CSF drainage at set pressure thresholds |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with subarachnoid hemorrhage
Key inclusion criteria (4 listed)
- Admitted to Duke University NCCU
- Adult (18 years of age or older)
- Primary diagnosis is Subarachnoid Hemorrhage
- Intraventricular catheter in situ
Key exclusion criteria (4 listed)
- Glasgow Coma Score = 3
- Hunt and Hess Score = 5
- Prisoners
- Ventriculostomy > 72 hours
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
Cerebral artery vasospasm
Time frame: 14 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2015.
- Derived from this study: PubMed 23957382Olson DM, Zomorodi M, Britz GW, Zomorodi AR, Amato A, Graffagnino C. Continuous cerebral spinal fluid drainage associated with complications in patients admitted with subarachnoid hemorrhage. J Neurosurg. 2013 Oct;119(4):974-80. doi: 10.3171/2013.6.JNS122403. Epub 2013 Aug 20.
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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.
DaiWai M Olson, PhD RN CCRN principal investigator
Duke University
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, run by Duke 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 4 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: stopped early, as of the sponsor's last update on 6 Apr 2015. 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 was stopped early. Results are not available in the source record.
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?
Cerebral artery vasospasm (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01169454, which also lists 1 linked publication.
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 6 Apr 2015.