Cerebrospinal Fluid (CSF) Drainage Study
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||High Volume Cerebrospinal Fluid Diversion in the Management of Aneurysmal Subarachnoid Hemorrhage: A Pilot Study|
- Modified Rankin Scale [ Time Frame: 90-days ] [ Designated as safety issue: No ]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.
- Infarction [ Time Frame: 90-days ] [ Designated as safety issue: No ]Presence of radiologic infarction
- Vasospasm [ Time Frame: 90-days ] [ Designated as safety issue: No ]Evidence of vasospams based upon TCD and/or angiography
- Shunt placement [ Time Frame: 90-days ] [ Designated as safety issue: No ]Rate of shunt placement
- Ventriculitis [ Time Frame: 90-days ] [ Designated as safety issue: No ]Rate of ventriculitis
- Modified Rankin Scale [ Time Frame: Hospital discharge (average 3 weeks) ] [ Designated as safety issue: No ]Modified rankin Scale upon discharge from the hospital
- MMSE [ Time Frame: 90-days ] [ Designated as safety issue: No ]Cognitive status evaluated using the MMSE
- Length of ICU stay [ Time Frame: Average 3 weeks ] [ Designated as safety issue: No ]Evalute the average length of ICU stay for this patient population.
|Study Start Date:||August 2011|
|Study Completion Date:||February 2013|
|Primary Completion Date:||February 2013 (Final data collection date for primary outcome measure)|
Experimental: High volume CSF diversion
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.
Procedure: CSF Diversion
Active Comparator: Conventional CSF diversion
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
Procedure: CSF Diversion
Please refer to this study by its ClinicalTrials.gov identifier: NCT01420978
|United States, Florida|
|Mayo Clinic in Florida|
|Jacksonville, Florida, United States, 32224|
|United States, Minnesota|
|Mayo Clinic in Rochester|
|Rochester, Minnesota, United States, 55905|
|Principal Investigator:||Giuseppe Lanzino, MD||Mayo Clinic|