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

August 15, 2011
May 12, 2013
August 2011
February 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01420978 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Aneurysmal Subarachnoid Hemorrhage
Procedure: CSF Diversion
CSF drainage
  • 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.
    Intervention: Procedure: CSF Diversion
  • 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
    Intervention: Procedure: CSF Diversion
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
February 2013
February 2013   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01420978
11-002713
No
Giuseppe Lanzino, Mayo Clinic
Mayo Clinic
Not Provided
Principal Investigator: Giuseppe Lanzino, MD Mayo Clinic
Mayo Clinic
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP