Cerebrospinal Fluid (CSF) Drainage Study
Primary Purpose
Aneurysmal Subarachnoid Hemorrhage
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CSF Diversion
Sponsored by
About this trial
This is an interventional treatment trial for Aneurysmal Subarachnoid Hemorrhage
Eligibility Criteria
Inclusion Criteria
- Age ≥ 18 years
- Diagnosis of acute subarachnoid hemorrhage (SAH), confirmed with noncontrast head CT
- SAH is suspected to be aneurysmal in source
- Clinical management requires placement of EVD within 2 days of suspected time of hemorrhage
Exclusion Criteria
- Age < 18 years
- SAH of traumatic or non-aneurysmal etiology
- Patients treated with lumbar drains
- EVD placement ≥ 3 days after suspected time of hemorrhage
- Known contraindication to induction of relative intracranial hypotension (e.g. acute subdural hematoma)
- Pre-morbid mRS ≥ 3
- EVD that is suboptimally placed by CT obtained after EVD placement (i.e. EVD not in the ventricular system)
Sites / Locations
- Mayo Clinic in Florida
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
High volume CSF diversion
Conventional CSF diversion
Arm Description
The EVD will be set to an initial level of 5 mmHg. The drain will remain in place at a level of ≤ 5 mmHg until at least day 10 after SAH before a weaning trial is attempted.
The EVD will be set to a level of 15 mmHg for as long as needed for the treatment of hydrocephalus, and subsequently weaned at the discretion of the treating physician. Lowering the level of the EVD can be considered by the treating physician if sustained intracranial hypertension occurs
Outcomes
Primary Outcome Measures
Modified Rankin Scale
The primary outcome is clinical outcome at 90 days. A favorable outcome is defined as a score of 1 or 2 on the modified Rankin Score (mRS) and poor outcome defined as a mRS of 3-6. This assessment will be made by a clinician who was blinded to the patient's CSF diversion treatment arm.
Secondary Outcome Measures
Infarction
Presence of radiologic infarction
Vasospasm
Evidence of vasospams based upon TCD and/or angiography
Shunt placement
Rate of shunt placement
Ventriculitis
Rate of ventriculitis
Modified Rankin Scale
Modified rankin Scale upon discharge from the hospital
MMSE
Cognitive status evaluated using the MMSE
Length of ICU stay
Evalute the average length of ICU stay for this patient population.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01420978
Brief Title
Cerebrospinal Fluid (CSF) Drainage Study
Official Title
High Volume Cerebrospinal Fluid Diversion in the Management of Aneurysmal Subarachnoid Hemorrhage: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
When patients suffer a subarachnoid hemorrhage (bleeding around the brain), they often develop hydrocephalus. This is an enlargement of the fluid-filled spaces (ventricles) in the brain. Standard-of-care treatment includes placing an external ventricular drain (EVD) to drain off fluid. Eventually the EVD is weaned with the goal of removing it. Occasionally a patient does not tolerate this and a permanent surgery needs to be done to internalize a shunt.
Though this is done commonly and routinely throughout the world, there are no good studies to address how to optimally set the EVD level and how fast to wean it. Most set the EVD to a level of around 15 mmHg. The investigators hypothesize that setting the EVD lower (which will allow higher volume Cerebrospinal Fluid (CSF) drainage through the EVD) will improve perfusion at the level of the microcirculation in the brain, and result in improved neurologic outcomes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aneurysmal Subarachnoid Hemorrhage
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High volume CSF diversion
Arm Type
Experimental
Arm Description
The EVD will be set to an initial level of 5 mmHg. The drain will remain in place at a level of ≤ 5 mmHg until at least day 10 after SAH before a weaning trial is attempted.
Arm Title
Conventional CSF diversion
Arm Type
Active Comparator
Arm Description
The EVD will be set to a level of 15 mmHg for as long as needed for the treatment of hydrocephalus, and subsequently weaned at the discretion of the treating physician. Lowering the level of the EVD can be considered by the treating physician if sustained intracranial hypertension occurs
Intervention Type
Procedure
Intervention Name(s)
CSF Diversion
Intervention Description
CSF drainage
Primary Outcome Measure Information:
Title
Modified Rankin Scale
Description
The primary outcome is clinical outcome at 90 days. A favorable outcome is defined as a score of 1 or 2 on the modified Rankin Score (mRS) and poor outcome defined as a mRS of 3-6. This assessment will be made by a clinician who was blinded to the patient's CSF diversion treatment arm.
Time Frame
90-days
Secondary Outcome Measure Information:
Title
Infarction
Description
Presence of radiologic infarction
Time Frame
90-days
Title
Vasospasm
Description
Evidence of vasospams based upon TCD and/or angiography
Time Frame
90-days
Title
Shunt placement
Description
Rate of shunt placement
Time Frame
90-days
Title
Ventriculitis
Description
Rate of ventriculitis
Time Frame
90-days
Title
Modified Rankin Scale
Description
Modified rankin Scale upon discharge from the hospital
Time Frame
Hospital discharge (average 3 weeks)
Title
MMSE
Description
Cognitive status evaluated using the MMSE
Time Frame
90-days
Title
Length of ICU stay
Description
Evalute the average length of ICU stay for this patient population.
Time Frame
Average 3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Age ≥ 18 years
Diagnosis of acute subarachnoid hemorrhage (SAH), confirmed with noncontrast head CT
SAH is suspected to be aneurysmal in source
Clinical management requires placement of EVD within 2 days of suspected time of hemorrhage
Exclusion Criteria
Age < 18 years
SAH of traumatic or non-aneurysmal etiology
Patients treated with lumbar drains
EVD placement ≥ 3 days after suspected time of hemorrhage
Known contraindication to induction of relative intracranial hypotension (e.g. acute subdural hematoma)
Pre-morbid mRS ≥ 3
EVD that is suboptimally placed by CT obtained after EVD placement (i.e. EVD not in the ventricular system)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Lanzino, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
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Cerebrospinal Fluid (CSF) Drainage Study
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