Cerebrospinal Fluid (CSF) Drainage Study

Study Overview
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Brief Summary
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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.

Official Title
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High Volume Cerebrospinal Fluid Diversion in the Management of Aneurysmal Subarachnoid Hemorrhage: A Pilot Study

Conditions
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Aneurysmal Subarachnoid Hemorrhage

Intervention / Treatment
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* Procedure: CSF Diversion


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High volume CSF diversion<br>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<br>* CSF drainage<br>|
| Active Comparator: Conventional CSF diversion<br>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<br>* CSF drainage<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 90-days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infarction | Presence of radiologic infarction | 90-days | 
| Vasospasm | Evidence of vasospams based upon TCD and/or angiography | 90-days | 
| Shunt placement | Rate of shunt placement | 90-days | 
| Ventriculitis | Rate of ventriculitis | 90-days | 
| Modified Rankin Scale | Modified rankin Scale upon discharge from the hospital | Hospital discharge (average 3 weeks) | 
| MMSE | Cognitive status evaluated using the MMSE | 90-days | 
| Length of ICU stay | Evalute the average length of ICU stay for this patient population. | Average 3 weeks |