We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01169454
First Posted: July 26, 2010
Last Update Posted: April 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Medtronic
Information provided by (Responsible Party):
Duke University
July 22, 2010
July 26, 2010
April 6, 2015
March 2009
September 2012   (Final data collection date for primary outcome measure)
Cerebral artery vasospasm [ Time Frame: 14 days ]
Same as current
Complete list of historical versions of study NCT01169454 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Not Provided
Not Provided
Non-Probability Sample
Patients with subarachnoid hemorrhage
Subarachnoid Hemorrhage
Not Provided
  • 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
September 2012
September 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01169454
Pro00016054
No
Not Provided
Not Provided
Duke University
Duke University
Medtronic
Principal Investigator: DaiWai M Olson, PhD RN CCRN Duke University
Duke University
April 2015