Lumbar vs Extraventricular Drains for Subarachnoid Hemorrhage

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Diego

Disqualifiers: Under 18

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 7 days

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial compares two methods to drain fluid from around the brain in patients with a specific type of brain bleed. The goal is to find out which method is better at preventing complications. By reducing pressure in the skull, these methods can help improve patient recovery.

Eligibility Criteria

This trial is for adults at UCSD Medical Center with a grade II, III, or IV subarachnoid hemorrhage (SAH) from a ruptured aneurysm and visible blood in brain scans. It excludes anyone under 18.

Inclusion Criteria

I have a grade II-IV subarachnoid hemorrhage or aneurysmal SAH confirmed by imaging.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are randomly assigned to either lumbar drain (LD) or extraventricular drain (EVD) for cerebrospinal fluid diversion

7 days

Daily monitoring in ICU

Follow-up

Participants are monitored for safety and effectiveness after treatment, including surveillance CT scans to assess clearance of cisternal blood and incidence of vasospasm

7 days

CT scans on day 1, 2-3, and 7

Long-term Follow-up

Participants are monitored for long-term outcomes such as the need for ventriculoperitoneal shunt and clinical improvement

Up to 14 days

Treatment Details

Interventions

• Extraventricular Drain
• Lumbar Drain

Trial Overview The study compares two methods to drain blood after SAH: extraventricular drain (EVD) and lumbar drain (LD). Patients will be randomly assigned to one of these treatments to see which better prevents vasospasm, reduces ICU stay, and lessens the need for permanent shunts.

Participant Groups

Group I: EVD Active Control 1 Intervention

Patients will have extraventricular drain to manage CSF subarachnoid blood.

Group II: LD Active Control 1 Intervention

Patients will have lumbar drain to manage CSF subarachnoid blood.

Who Is Running the Clinical Trial?

University of California, San Diego

Lead Sponsor

Trials

1,215

Recruited

1,593,000+