What side effects are associated with this type of intervention?

The most common treatments for subarachnoid hemorrhage involving cerebrospinal fluid drainage, such as Extraventricular Drain (EVD) and Lumbar Drain (LD), can have several side effects. These include infection, bleeding, and catheter-related complications such as blockage or dislodgement. Additionally, over-drainage can lead to headaches, subdural hematomas, and intracranial hypotension. Monitoring and managing these side effects are crucial to ensure the effectiveness and safety of the treatment.

What prior FDA approvals exist?

There are no specific FDA-approved drugs mentioned in the provided context for the treatment of Subarachnoid Hemorrhage (SAH) that focus on cerebrospinal fluid drainage methods like Extraventricular Drain (EVD) and Lumbar Drain (LD). These methods are primarily procedural interventions aimed at reducing subarachnoid blood and preventing vasospasm, rather than pharmacological treatments. The context does not provide detailed information on FDA approvals for these specific procedures.

What other types of research exist?

As of 2024, promising novel alternatives to EVD and LD for subarachnoid hemorrhage patients include endovascular techniques such as intra-arterial vasodilator therapy (e.g., using nicardipine or verapamil) and the use of intrathecal thrombolytics to enhance the clearance of subarachnoid blood. Additionally, advancements in neuroprotective agents and targeted molecular therapies aimed at reducing vasospasm and improving outcomes are under investigation. These methods focus on minimizing invasive procedures while maximizing therapeutic efficacy.

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Lumbar vs Extraventricular Drains for Subarachnoid Hemorrhage

N/A

Recruiting

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients received at the UCSD Medical Center with grade II, III, IV subarachnoid hemorrhage or patients with aneurysmal SAH with radiographic evidence.

Be older than 18 years old

Must not have

Patients under the age of 18, excluding minors from this study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0-14 days

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort at the drainage site, infection risk around the brain or spine where drains are placed, possible bleeding during insertion or removal of drains, and headaches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0-14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Vasopasm

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: EVDActive Control1 Intervention

Patients will have extraventricular drain to manage CSF subarachnoid blood.

Group II: LDActive Control1 Intervention

Patients will have lumbar drain to manage CSF subarachnoid blood.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The primary treatments for subarachnoid hemorrhage (SAH) include the use of extraventricular drains (EVD) and lumbar drains (LD) to remove cerebrospinal fluid (CSF) and reduce the amount of subarachnoid blood. These drainage methods help to alleviate intracranial pressure and reduce the risk of vasospasm, a common and severe complication of SAH that can lead to significant neurological deficits or death. By effectively managing the volume of subarachnoid blood, these treatments aim to prevent the narrowing of blood vessels (vasospasm) and ensure adequate cerebral perfusion, which is crucial for the recovery and prognosis of SAH patients.