What this study is
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.
What's being tested
- Extraventricular Drain
Intervention · DEVICE
As mentioned above, intervention will take place to promote subarachnoid blood diversion from cerebrospinal fluid after ruptured intracranial aneurysm.
- Lumbar Drain
Intervention · DEVICE
Study details
- Official title
- Lumbar Drainage Compared With Extraventricular Drainage of Cerebral Spinal Fluid in Treatment of Patients With Subarachnoid Hemorrhage - a Prospective Randomized Controlled Trial
- Sponsor
- University of California, San Diego
- Conditions
- Vasospasm, Intracranial · Subarachnoid Hemorrhage
- Enrolling
- 100 people
- Starts
- 2017-01-01
- Est. completion
- 2027-01-04
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 110 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Patients received at the UCSD Medical Center with grade II, III, IV subarachnoid hemorrhage or patients with aneurysmal SAH with radiographic evidence.
You can't join if
- Patients under the age of 18, excluding minors from this study
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUCSD Medical Center
San Diego, California, United States
- David R Santiago-Dieppa, MD · Contact6195435078drsantiagodieppa@ucsd.edu
- David R Santiago-Dieppa, MD · Sub-investigator
Recruiting
Study team
Sponsor
University of California, San Diego
Study ID 160719
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.