Cerebrospinal Fluid (CSF) Drainage Study

Aneurysmal Subarachnoid Hemorrhage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01420978
• Other study ID #: 11-002713
• Status: Completed
• Phase: N/A
• First received: August 15, 2011
• Last updated: May 12, 2013
• Start date: August 2011
• Est. completion date: February 2013

Study information

• Verified date: May 2013
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aneurysmal Subarachnoid Hemorrhage
• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

Procedure:
• CSF Diversion
CSF drainage

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Infarction	Presence of radiologic infarction	90-days	No
Secondary	Vasospasm	Evidence of vasospams based upon TCD and/or angiography	90-days	No
Secondary	Shunt placement	Rate of shunt placement	90-days	No
Secondary	Ventriculitis	Rate of ventriculitis	90-days	No
Secondary	Modified Rankin Scale	Modified rankin Scale upon discharge from the hospital	Hospital discharge (average 3 weeks)	No
Secondary	MMSE	Cognitive status evaluated using the MMSE	90-days	No
Secondary	Length of ICU stay	Evalute the average length of ICU stay for this patient population.	Average 3 weeks	No