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

This study has been terminated.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01169454
First received: July 22, 2010
Last updated: November 15, 2012
Last verified: November 2012

July 22, 2010
November 15, 2012
March 2009
December 2012   (final data collection date for primary outcome measure)
Cerebral artery vasospasm [ Time Frame: 14 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01169454 on ClinicalTrials.gov Archive Site
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Ventriculostomy in Subarachnoid Hemorrhage (SAH): Intracranial Pressure (ICP) Open or Not?
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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

Patients with subarachnoid hemorrhage

Subarachnoid Hemorrhage
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  • 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
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.
 
Terminated
60
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01169454
Pro00016054
No
Duke University
Duke University
Medtronic
Principal Investigator: DaiWai M Olson, PhD RN CCRN Duke University
Duke University
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP