Cerebrospinal Fluid (CSF) Drainage Study

Not Applicable

Completed

• Conditions: Aneurysmal Subarachnoid Hemorrhage
• Interventions: Procedure: CSF Diversion

• Registration Number: NCT01420978
• Lead Sponsor: Mayo Clinic

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-15
• Study First Submitted QC: 2011-08-19
• Study First Posted: 2011-08-22
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-12
• Last Update Posted: 2013-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High volume CSF diversion	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.
Conventional CSF diversion	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

Primary Outcome Measures

Name	Time	Method
Modified Rankin Scale	90-days	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

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

Trial Locations

Locations (2)

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States