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

Subarachnoid Hemorrhage Clinical Trial

— VISION 2  

Official title:

Ventriculostomy in SAH: ICP Open or Not?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01169454
• Other study ID #: Pro00016054
• Status: Terminated
• Phase: N/A
• First received: July 22, 2010
• Last updated: April 3, 2015
• Start date: March 2009
• Est. completion date: September 2012

Study information

• Verified date: April 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Medtronic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cerebral artery vasospasm		14 days	No