Cerebrospinal Fluid (CSF) Drainage Study

NCT ID: NCT01420978

Last Updated: 2013-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2013-02-28

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.

Conditions

Aneurysmal Subarachnoid Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

CSF Diversion

Intervention Type: PROCEDURE

CSF drainage

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

Group Type: ACTIVE_COMPARATOR

CSF Diversion

Intervention Type: PROCEDURE

CSF drainage

Interventions

CSF Diversion

CSF drainage

Intervention Type: PROCEDURE

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Giuseppe Lanzino

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giuseppe Lanzino, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Florida

Jacksonville, Florida, United States

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

11-002713

Identifier Type: -

Identifier Source: org_study_id