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Cervical Sympathetic Block for Cerebral Vasospasm

N/A

Waitlist Available

Led By Anna Maria Bombardieri, MD, PhD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

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

Must have

Patients hospitalized in the ICU and developing cerebral vasospasm after aneurysmal subarachnoid hemorrhage

Patients aged 18 and over

Must not have

Known advanced stage kidney disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up duration of recovery in icu (1-2 weeks)

Awards & highlights

No Placebo-Only Group

Summary

This trial will assess if a cervical sympathetic block can improve cerebral blood flow & neurological function in people with aneurysm-related brain issues.

Who is the study for?

This trial is for adults over 18 who are in the ICU with cerebral vasospasm following a brain aneurysm bleed. It's not suitable for those with advanced kidney disease.

What is being tested?

The study tests whether a cervical sympathetic block, which is an injection near the neck to interrupt nerve signals, can improve blood flow in the brain and neurological recovery after a subarachnoid hemorrhage.

What are the potential side effects?

Potential side effects of cervical sympathetic block may include soreness or bruising at the injection site, temporary difficulty swallowing, hoarseness, and less commonly, drooping eyelid or pupil constriction.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am in the ICU due to brain vessel spasms after a brain bleed from an aneurysm.

Select...

I am 18 years old or older.

Exclusion Criteria

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

Select...

My kidney disease is in an advanced stage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ duration of recovery in icu (1-2 weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~duration of recovery in icu (1-2 weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of recovery in icu (1-2 weeks) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Cerebral blood flow

Neurological function

Secondary study objectives

Cerebral blood flow velocity

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Cervical sympathetic blockExperimental Treatment1 Intervention

Patients hospitalized in the ICU and developing clinical manifestations of cerebral vasospasm will undergo a computerized tomography (CT) angiography and a CT perfusion scan. If the vasospasm will be confirmed by the CT imaging, a cervical sympathetic nerve block under ultrasound guidance will be performed. The block consists in the deposition of local anesthetic at the cervical sympathetic ganglion that will be visualized with an ultrasound device. A periganglionar catheter will be left in place. A CT angiography and CT perfusion will be repeated to check the effect of the block on the brain vasculature after the block is done. Patients will have a daily monitoring of their neurological function and of their cerebral blood flow with transcranial doppler in the ICU.

0 / 3Eligibility criteria met