Cervical Sympathetic Block in Patients With Cerebral Vasospasm

October 2, 2023 updated by: Anna Maria Bombardieri, Stanford University

Cervical Sympathetic Block to Increase Cerebral Blood Flow in Patients With Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage

The purposes of this study are twofold: 1) to assess the effect of a cervical sympathetic block on cerebral blood flow in patients suffering from cerebral vasospasm, after aneurysmal subarachnoid hemorrhage; 2) to evaluate the effect of the sympathetic block on the recovery of the neurological function.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Patients hospitalized in the intensive care unit (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.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • ages 18 and over
  • patients hospitalized in the ICU and developing cerebral vasospasm after aneurysmal subarachnoid hemorrhage

Exclusion Criteria:

- known advanced stage kidney disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cervical sympathetic block

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.
Procedure: Cervical sympathetic block
All participants will get the cervical sympathetic block and catheter under ultrasound guidance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral blood flow
Time Frame: 1 hour after the block
Cerebral blood flow as measured by computed tomography perfusion
1 hour after the block
Neurological function
Time Frame: Duration of recovery in ICU (1-2 weeks)
Change in neurological status as assessed by the Glasgow Coma Scale. The Glasgow Coma Scale score can range from 3 (completely unresponsive) to 15 (responsive).
Duration of recovery in ICU (1-2 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cerebral blood flow velocity
Time Frame: Daily during recovery in ICU (1-2 weeks)
Transcranial doppler measurement
Daily during recovery in ICU (1-2 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Investigators

  • Principal Investigator: Anna Maria Bombardieri, MD, PhD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 27, 2023

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 19, 2022

First Submitted That Met QC Criteria

February 7, 2022

First Posted (Actual)

February 8, 2022

Study Record Updates

Last Update Posted (Actual)

October 5, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 64105

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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