Recruiting

Lumbar Drain vs. Extraventricular Drain

Sponsor:

UCLA

Code:

NCT03065231

Conditions

Vasospasm, Intracranial

Subarachnoid Hemorrhage

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Extraventricular Drain

Lumbar Drain

Study Details

Brief summary:

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.

Conditions

Vasospasm, Intracranial

Subarachnoid Hemorrhage

Study ID

NCT03065231

Start date

Jan 1, 2017

Status verified date

Feb, 2025

Completion date

Jan 4, 2027

Anticipated

Primary completion date

Jan 4, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • patients received at the UCSD Medical Center with grade II, III, IV subarachnoid hemorrhage or patients with aneurysmal SAH with radiographic evidence.

Exclusion Criteria:

  • patients under the age of 18, excluding minors from this study

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Extraventricular Drain

As mentioned above, intervention will take place to promote subarachnoid blood diversion from cerebrospinal fluid after ruptured intracranial aneurysm.

Lumbar Drain

Primary outcome measure

  • Vasopasm [ Time Frame: 0-14 days ]

Central Contacts and Locations

Locations

UCSD Medical Center

Recruiting

San Diego, California, United States, 92103

Contacts

David R Santiago-Dieppa, MD

6195435078drsantiagodieppa@ucsd.edu

More Information

Sponsor

University of California, San Diego

Last update posted

Mar 4, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2025-03-04.