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

Sponsor
Duke University (Other)
Overall Status
Terminated
CT.gov ID
NCT01169454
Collaborator
Medtronic (Industry)
60
Enrollment
1
Location
42.1
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

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 Intervention/Treatment Phase

    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 :
    Mar 1, 2009
    Actual Primary Completion Date :
    Sep 1, 2012
    Actual Study Completion Date :
    Sep 1, 2012

    Arms and Interventions

    Arm Intervention/Treatment
    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 [14 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Duke University Medical Center Durham North Carolina United States 27710

    Sponsors and Collaborators

    • Duke University
    • Medtronic

    Investigators

    • Principal Investigator: DaiWai M Olson, PhD RN CCRN, Duke University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Duke University
    ClinicalTrials.gov Identifier:
    NCT01169454
    Other Study ID Numbers:
    • Pro00016054
    First Posted:
    Jul 26, 2010
    Last Update Posted:
    Apr 6, 2015
    Last Verified:
    Apr 1, 2015
    Keywords provided by Duke University
    Cerebral Spinal Fluid
    Ventriculostomy
    Subarachnoid hemorrhage
    Vasospasm
    Human Subjects
    Additional relevant MeSH terms:
    Subarachnoid Hemorrhage
    Hemorrhage

    Study Results

    No Results Posted as of Apr 6, 2015