Cerebrospinal Fluid (CSF) Drainage Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Giuseppe Lanzino, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01420978
First received: August 15, 2011
Last updated: May 12, 2013
Last verified: May 2013
  Purpose

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 Intervention
Aneurysmal Subarachnoid Hemorrhage
Procedure: CSF Diversion

Study Type: Interventional
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

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 20
Study Start Date: August 2011
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01420978

Locations
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
Investigators
Principal Investigator: Giuseppe Lanzino, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Giuseppe Lanzino, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01420978     History of Changes
Other Study ID Numbers: 11-002713
Study First Received: August 15, 2011
Last Updated: May 12, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 22, 2014