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Trial record 38 of 195 for:    Hemorrhage AND SAH

Ventriculostomies in SAH: ICP Open or Not? (VISION)

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ClinicalTrials.gov Identifier: NCT00787020
Recruitment Status : Completed
First Posted : November 7, 2008
Results First Posted : December 17, 2010
Last Update Posted : November 3, 2015
Sponsor:
Information provided by (Responsible Party):
Duke University

Study Type Observational
Study Design Observational Model: Case Control;   Time Perspective: Prospective
Condition Subarachnoid Hemorrhage
Enrollment 37
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ventriculostomy Open Ventriculostomy Monitored
Hide Arm/Group Description Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag. Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.
Period Title: Overall Study
Started 24 13
Completed 24 13
Not Completed 0 0
Arm/Group Title Ventriculostomy Open Ventriculostomy Monitored Total
Hide Arm/Group Description Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag. Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician. Total of all reporting groups
Overall Number of Baseline Participants 24 13 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 13 participants 37 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
20
  83.3%
10
  76.9%
30
  81.1%
>=65 years
4
  16.7%
3
  23.1%
7
  18.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 13 participants 37 participants
55.92  (13.35) 53.13  (11.13) 54.11  (11.85)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 13 participants 37 participants
Female
16
  66.7%
9
  69.2%
25
  67.6%
Male
8
  33.3%
4
  30.8%
12
  32.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 24 participants 13 participants 37 participants
24 13 37
1.Primary Outcome
Title Cerebral Artery Vasospasm
Hide Description Cerebral artery vasospasm is defined as transcranial doppler mean velocity greater than 120 or angiographic vasospasm determined by cerebral angiogram.
Time Frame 14 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ventriculostomy Open Ventriculostomy Monitored
Hide Arm/Group Description:
Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.
Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.
Overall Number of Participants Analyzed 24 13
Measure Type: Number
Unit of Measure: Participants
16 7
2.Secondary Outcome
Title External Ventricular Drain (EVD) Complications
Hide Description External ventricular drain complications are defined as ventriculitis, shunt dependency, ventricular catheter obstruction requiring manipulation, or removal by the patient.
Time Frame 14 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ventriculostomy Open Ventriculostomy Monitored
Hide Arm/Group Description:
Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.
Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.
Overall Number of Participants Analyzed 24 13
Measure Type: Number
Unit of Measure: Participants
14 4
3.Secondary Outcome
Title Cerebrospinal Fluid (CSF) Output Per Day
Hide Description [Not Specified]
Time Frame 14 Days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Ventriculostomy Open Ventriculostomy Monitored
Hide Arm/Group Description:
Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag.
Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.
Overall Number of Participants Analyzed 24 13
Mean (95% Confidence Interval)
Unit of Measure: Milliliter
134
(116.9 to 151.1)
135
(112.2 to 157.8)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ventriculostomy Open Ventriculostomy Monitored
Hide Arm/Group Description Subjects are treated with near continuous cerebrospinal fluid (CSF) diversion by position the stopcock in the open position and the intracranial pressure (ICP) is monitored each hour: CSF drains into an external ventricular drainage bag. Subjects are treated with intermittent cerebrospinal fluid (CSF) diversion. Intracranial pressure (ICP) is monitored and CSF is drained only when the ICP exceeds a threshold dictated by the attending physician.
All-Cause Mortality
Ventriculostomy Open Ventriculostomy Monitored
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ventriculostomy Open Ventriculostomy Monitored
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ventriculostomy Open Ventriculostomy Monitored
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/13 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: DaiWai M Olson
Organization: Duke University Medical Center
Phone: 9196683751
Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT00787020     History of Changes
Other Study ID Numbers: Pro00005900
First Submitted: November 6, 2008
First Posted: November 7, 2008
Results First Submitted: October 6, 2010
Results First Posted: December 17, 2010
Last Update Posted: November 3, 2015