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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best method to drain blood from around the brain after a blood vessel bursts. It compares extraventricular drains (EVD) and lumbar drains (LD) to determine which better prevents issues like vasospasm, a narrowing of blood vessels that can lead to brain damage. Researchers observe participants to assess whether either method reduces blood in the brain area, shortens ICU stays, and decreases the need for long-term drainage solutions. The trial seeks individuals who have experienced a specific type of brain bleed, known as subarachnoid hemorrhage, and have received treatment at the UCSD Medical Center. As an unphased trial, it offers participants the chance to contribute to significant research that could enhance future treatment options for brain bleeds.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these drainage methods are safe for managing subarachnoid hemorrhage?

Research has shown that both extraventricular drains (EVD) and lumbar drains (LD) are safe and effective for treating subarachnoid hemorrhage (SAH), which involves bleeding around the brain.

Studies indicate that EVD can be effective, but some risks exist. EVD may lead to complications such as infections (about a 2% risk) and small brain bleeds (about a 9% risk). Although these risks are not very high, they are important to consider.

Research has found that LD generally involves fewer complications than EVD. Specifically, LD has lower rates of bleeding and infections, suggesting that lumbar drains might be somewhat safer than extraventricular drains overall.

In summary, both treatments help manage SAH, but LD might be slightly safer due to fewer complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the comparison between extraventricular drains (EVDs) and lumbar drains (LDs) for managing subarachnoid hemorrhage because these techniques could offer different benefits over traditional treatments. EVDs directly manage cerebrospinal fluid (CSF) and subarachnoid blood, potentially allowing for precise control of intracranial pressure, which is crucial after a hemorrhage. On the other hand, LDs might offer a less invasive approach, reducing the risk of complications like infections. By comparing these two methods, researchers hope to determine which approach provides better outcomes for patients, paving the way for improved treatment strategies in the future.

What evidence suggests that this trial's treatments could be effective for preventing vasospasm in subarachnoid hemorrhage?

This trial will compare extraventricular drains (EVD) and lumbar drains (LD) for managing cerebrospinal fluid and subarachnoid blood. Research has shown that EVDs are crucial for treating serious conditions like hydrocephalus, a buildup of fluid in the brain, and high brain pressure after bleeding around the brain. However, studies suggest that lumbar drains might lead to better long-term outcomes. Specifically, patients with lumbar drains experienced fewer issues such as secondary infarctions, where brain tissue dies, and demonstrated better neurological recovery six months after treatment. Some evidence even suggests that lumbar drainage could reduce the risk of vasospasm, the narrowing of blood vessels, and serious disability. While both methods help remove excess blood and fluid, lumbar drains seem to offer benefits in reducing complications and improving recovery. ^{4 5 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5858985/

External Ventricular Drains After Subarachnoid Hemorrhage External ventricular drains (EVD) are essential in the early management of hydrocephalus and elevated intracranial pressure after subarachnoid hemorrhage.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0967586825004151

A systematic review of combined ventricular and lumbar ... Patients with aSAH may benefit of dual CSF drainage, especially in case of massive bleeding. Preliminary data suggest that it may reduce vasospasm and improve ...

3. thejns.org thejns.org/view/journals/j-neurosurg/142/6/article-p1599.xml

Outcomes and complications of external ventricular drainage ... During EVD treatment, 38.8% of patients experienced complications, including complete occlusion (17.2%), partial occlusion (16.1%), ...

4. jamanetwork.com jamanetwork.com/journals/jamaneurology/fullarticle/2806583

Effectiveness of Lumbar Cerebrospinal Fluid Drain Among ... In this trial, among patients with aneurysmal subarachnoid hemorrhage, lumbar drainage improved clinical neurological outcomes at 6 months.

5. journals.sagepub.com journals.sagepub.com/doi/10.1177/17474930251361211

Outcomes of external ventricular drainage and lumbar ... In this pairwise meta-analysis, LD was associated with lower rates of vasospasm, ischemic complications, severe disability, and mortality ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40662333/

Outcomes of external ventricular drainage and lumbar ... Conclusion: LD was associated with lower rates of vasospasm, ischemic complications, severe disability, and mortality compared to non-LD, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11569757/

Comparison of safety of lumbar drain versus external ... Symptomatic HCP after aneurysmal SAH can be effectively and safely treated with LD. LD had lower overall complications than EVD with no hemorrhage, infection ...

8. neurology.org neurology.org/doi/10.1212/WNL.98.18_supplement.2039

Association of External Ventricular Drain Duration and ... EVD related complications such as infections (2%) and tract hemorrhage (9%) were non-significantly higher in patients with longer EVD duration.