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Completed

NCT Number: NCT01420978

Cerebrospinal Fluid (CSF) Drainage 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.

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Key information

Conditions

Aneurysmal Subarachnoid Hemorrhage Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhage Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Subarachnoid Hemorrhage Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Florida, Jacksonville, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CSF Diversion

Procedure

CSF drainage

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 22, 2011
Registry last updated
May 14, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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