NCT03065231 · University of California, San Diego
Lumbar Drain vs Extraventricular Drain to Prevent Vasospasm in Subarachnoid Hemorrhage
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Extraventricular Drain
As mentioned above, intervention will take place to promote subarachnoid blood diversion from cerebrospinal fluid after ruptured intracranial aneurysm.
DEVICE
Lumbar Drain
Primary outcome measures
Vasopasm
Time frame: 0-14 days
Clinical and Radiographic incidence of vasospasm after ruptured intracranial aneurysm
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- San Diego, California
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 4, 2025 · Source of record for eligibility and locations