Comparing lumbar and extraventricular drains to prevent complications after brain hemorrhage
Lumbar Drainage Compared With Extraventricular Drainage of Cerebral Spinal Fluid in Treatment of Patients With Subarachnoid Hemorrhage - a Prospective Randomized Controlled Trial
This study is testing whether using a lumbar drain or an extraventricular drain helps prevent complications in patients who have had a brain hemorrhage.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 110 Years |
| Sex | All |
| Sponsor | University of California, San Diego Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT03065231 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of two drainage methods, lumbar drain (LD) and extraventricular drain (EVD), in preventing vasospasm in patients who have experienced subarachnoid hemorrhage. Patients admitted to UCSD Hillcrest or Thornton Hospital will be randomly assigned to receive either LD or EVD as part of their treatment. The study will observe outcomes such as the incidence of clinical vasospasm, the amount of subarachnoid blood, length of ICU stay, and the need for permanent ventriculoperitoneal shunt. This prospective randomized controlled trial seeks to establish clearer guidelines for the optimal drainage method in these patients.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with Fisher Grade II, III, or IV subarachnoid hemorrhage or those with aneurysmal subarachnoid hemorrhage showing signs of hydrocephalus.
Not a fit: Patients with obstructive hydrocephalus, mass lesions preventing lumbar drain placement, pregnant individuals, or minors under 18 will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols that reduce the risk of vasospasm and enhance recovery for patients with subarachnoid hemorrhage.
How similar studies have performed: While previous studies have compared these drainage methods retrospectively, this prospective randomized approach is novel and aims to provide definitive evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
San Diego, California
- UCSD Medical Center — San Diego, California, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.