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Ventriculostomy in Subarachnoid Hemorrhage (SAH): Intracranial Pressure (ICP) Open or Not?

Ventriculostomy in SAH: ICP Open or Not?

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01169454
Acronym
VISION 2
Enrollment
60
Registered
2010-07-26
Start date
2009-03-31
Completion date
2012-09-30
Last updated
2015-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subarachnoid Hemorrhage

Keywords

Cerebral Spinal Fluid, Ventriculostomy, Subarachnoid hemorrhage, Vasospasm, Human Subjects

Brief 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). 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.

Interventions

None listed

Sponsors

Medtronic
CollaboratorINDUSTRY
Duke University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Admitted to Duke University NCCU * Adult (18 years of age or older) * Primary diagnosis is Subarachnoid Hemorrhage * Intraventricular catheter in situ

Exclusion criteria

* Glasgow Coma Score = 3 * Hunt and Hess Score = 5 * Prisoners * Ventriculostomy \> 72 hours

Design outcomes

Primary

MeasureTime frame
Cerebral artery vasospasm14 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026