Cerebrospinal Fluid (CSF) Drainage Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01420978
Recruitment Status : Completed
First Posted : August 22, 2011
Last Update Posted : May 14, 2013
Information provided by (Responsible Party):
Giuseppe Lanzino, 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.

Condition or disease Intervention/treatment Phase
Aneurysmal Subarachnoid Hemorrhage Procedure: CSF Diversion Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: High Volume Cerebrospinal Fluid Diversion in the Management of Aneurysmal Subarachnoid Hemorrhage: A Pilot Study
Study Start Date : August 2011
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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

Primary Outcome Measures :
  1. Modified Rankin Scale [ Time Frame: 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 :
  1. Infarction [ Time Frame: 90-days ]
    Presence of radiologic infarction

  2. Vasospasm [ Time Frame: 90-days ]
    Evidence of vasospams based upon TCD and/or angiography

  3. Shunt placement [ Time Frame: 90-days ]
    Rate of shunt placement

  4. Ventriculitis [ Time Frame: 90-days ]
    Rate of ventriculitis

  5. Modified Rankin Scale [ Time Frame: Hospital discharge (average 3 weeks) ]
    Modified rankin Scale upon discharge from the hospital

  6. MMSE [ Time Frame: 90-days ]
    Cognitive status evaluated using the MMSE

  7. Length of ICU stay [ Time Frame: Average 3 weeks ]
    Evalute the average length of ICU stay for this patient population.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Giuseppe Lanzino, MD Mayo Clinic

Responsible Party: Giuseppe Lanzino, MD, Mayo Clinic Identifier: NCT01420978     History of Changes
Other Study ID Numbers: 11-002713
First Posted: August 22, 2011    Key Record Dates
Last Update Posted: May 14, 2013
Last Verified: May 2013

Additional relevant MeSH terms:
Subarachnoid Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases