Cerebrospinal Fluid (CSF) Drainage Study

High Volume Cerebrospinal Fluid Diversion in the Management of Aneurysmal Subarachnoid Hemorrhage: A Pilot 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 Overview

• Status: Completed
• Conditions: Aneurysmal Subarachnoid Hemorrhage
• Intervention / Treatment: Procedure: CSF Diversion

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic in Florida
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; CSF drainage
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; CSF drainage

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Giuseppe Lanzino, MD, Mayo Clinic

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): February 1, 2013

Study Registration Dates

• First Submitted: August 15, 2011
• First Submitted That Met QC Criteria: August 19, 2011
• First Posted (Estimate): August 22, 2011

Study Record Updates

• Last Update Posted (Estimate): May 14, 2013
• Last Update Submitted That Met QC Criteria: May 12, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Subarachnoid Hemorrhage
• Other Study ID Numbers: 11-002713