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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
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date July 22, 2010
First Posted Date July 26, 2010
Last Update Posted Date April 6, 2015
Study Start Date March 2009
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 23, 2010)
Cerebral artery vasospasm [ Time Frame: 14 days ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01169454 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ventriculostomy in Subarachnoid Hemorrhage (SAH): Intracranial Pressure (ICP) Open or Not?
Official Title Ventriculostomy in SAH: ICP Open or Not?
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.

Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with subarachnoid hemorrhage
Condition Subarachnoid Hemorrhage
Intervention Not Provided
Study Groups/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
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Terminated
Actual Enrollment
 (submitted: November 15, 2012)
60
Original Estimated Enrollment
 (submitted: July 23, 2010)
100
Actual Study Completion Date September 2012
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01169454
Other Study ID Numbers Pro00016054
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Duke University
Study Sponsor Duke University
Collaborators Medtronic
Investigators
Principal Investigator: DaiWai M Olson, PhD RN CCRN Duke University
PRS Account Duke University
Verification Date April 2015