Lumbar Drain vs Extraventricular Drain to Prevent Vasospasm in Subarachnoid Hemorrhage

Part of paid clinical trials in San Diego, California.

Sponsor
University of California, San Diego
Study ID
NCT03065231
Status
Recruiting
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Conditions

  • Subarachnoid Hemorrhage
  • Vasospasm, Intracranial

Eligibility Criteria

Sex
ALL
Age
18 Years - 110 Years
Healthy Volunteers
Not accepted

Interventions

  • Extraventricular Drain — DEVICE
    As mentioned above, intervention will take place to promote subarachnoid blood diversion from cerebrospinal fluid after ruptured intracranial aneurysm.
  • Lumbar Drain — DEVICE

Study Details

Vasospasm is a common complication after rupture of intracranial aneurysms causing devastating neurologic deficits and death. Vasospasm has been directly associated with the amount of subarachnoid blood inside the basal cisterns. Prior literature has attempted to refine treatment of ruptured intracranial aneurysms but does not have clear guidelines on the optimal method to drain subarachnoid blood. Two methods, extraventricular drain (EVD) and lumbar drain (LD) have been compared retrospectively yet remain controversial as to which method is optimal in reducing subarachnoid blood and preventing vasospasm. This study would be a prospective randomized trial in which patients would be assigned to EVD or LD and observed to see if one method of intervention is associated with preventing clinical vasospasm, decreasing subarachnoid blood, shortening overall ICU stay, and reducing the need for a permanent ventriculoperitoneal shunt. The conclusions of this study may identify an optimal treatment modality to benefit all future patients with ruptured intracranial aneurysms.

Key Dates

Start date
Jan 1, 2017
Status verified
Feb 2025
Primary completion
Jan 4, 2027
Completion
Jan 4, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: EVD
    Patients will have extraventricular drain to manage CSF subarachnoid blood.
  • Active Comparator: LD
    Patients will have lumbar drain to manage CSF subarachnoid blood.

Primary Outcome Measure

Vasopasm [ Time Frame: 0-14 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
UCSD Medical CenterSan DiegoCalifornia92103
David R Santiago-Dieppa, MD
[email protected]
6195435078
David R Santiago-Dieppa, MD (SUB_INVESTIGATOR)

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By research site
UCSD Medical Center· San Diego, CA

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