NCT01420978

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 22, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

May 14, 2013

Status Verified

May 1, 2013

Enrollment Period

1.5 years

First QC Date

August 15, 2011

Last Update Submit

May 12, 2013

Conditions

Aneurysmal Subarachnoid Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Infarction

    90-days

  • Vasospasm

    90-days

  • Shunt placement

    90-days

  • Ventriculitis

    90-days

  • Modified Rankin Scale

    Hospital discharge (average 3 weeks)

  • +2 more secondary outcomes

Study Arms (2)

High volume CSF diversion

EXPERIMENTAL

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

Conventional CSF diversion

ACTIVE COMPARATOR

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

Interventions

CSF DiversionPROCEDURE

CSF drainage

Conventional CSF diversionHigh volume CSF diversion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Giuseppe Lanzino, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 15, 2011

First Posted

August 22, 2011

Study Start

August 1, 2011

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

May 14, 2013

Record last verified: 2013-05

Locations

US(2)