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Ventriculostomy in Subarachnoid Hemorrhage (SAH): Intracranial Pressure (ICP) Open or Not? (VISION 2)

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ClinicalTrials.gov Identifier: NCT01169454
Recruitment Status : Terminated
First Posted : July 26, 2010
Last Update Posted : April 6, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Subarachnoid Hemorrhage

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

Study Type : Observational
Actual Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Ventriculostomy in SAH: ICP Open or Not?
Study Start Date : March 2009
Primary Completion Date : September 2012
Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :
  1. Cerebral artery vasospasm [ Time Frame: 14 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with subarachnoid hemorrhage

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01169454

United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Principal Investigator: DaiWai M Olson, PhD RN CCRN Duke University
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01169454     History of Changes
Other Study ID Numbers: Pro00016054
First Posted: July 26, 2010    Key Record Dates
Last Update Posted: April 6, 2015
Last Verified: April 2015

Keywords provided by Duke University:
Cerebral Spinal Fluid
Subarachnoid hemorrhage
Human Subjects

Additional relevant MeSH terms:
Subarachnoid Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases