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"The Effect of Stellate Ganglion Block in Severe Brain Injury"

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04208477
Recruitment Status : Not yet recruiting
First Posted : December 23, 2019
Last Update Posted : October 19, 2020
Sponsor:
Information provided by (Responsible Party):
Ivan Kostadinov, University Medical Centre Ljubljana

Brief Summary:
Blood flow through the brain is reduced after brain damage. Secondary brain ischemia caused by hypoxia and hypotension, further increase the susceptibility of the ischemically compromised brain to secondary impairment during this period. In order to determine whether and to what extent blockage of the stellate ganglion (BSG) affects the blood flow to the injured brain, the investigators will measure the variables of brain blood flow before and after BSG using computed tomography angiography (CTA), trans-cranial Doppler ultrasound (TCD), intracranial pressure (ICP) and perfusion computed tomography (PCT) of the brain. At the same time, the investigators would like to evaluate whether and to what extent BSG affects the aseptic inflammatory brain injury response and the biochemical indicators of brain damage in patients with moderate and severe brain injury.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Brain Inflammation Cerebral Vasospasm Procedure: one site blockade of the stellate ganglion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: "The Effect of Stellate Ganglion Block on Brain Haemodynamics and the Inflammatory Response in Moderate and Severe Brain Injury"
Estimated Study Start Date : November 1, 2020
Estimated Primary Completion Date : June 1, 2021
Estimated Study Completion Date : September 1, 2022

Arm Intervention/treatment
Experimental: BSG patients Procedure: one site blockade of the stellate ganglion
Ultrasound guided one site blockade of the stellate ganglion.




Primary Outcome Measures :
  1. Change in diameter of the cerebral arteries [ Time Frame: First measurement of the diameter will be done on the CTA made during the first week of hospitalization. Control measurement will be done 1 hour after the BSG. ]
    Diameters of the cerebral arteries will be measured in millimeters (mm) on the CTA before and after BSG. Measurement of the diameter will be done on standard positions: middle third of M1 segment and upper part of M2 segment of middle cerebral artery, middle third of A1 and A2 segment of anterior cerebral artery, P1 segment and first part of P2 segment of posterior cerebral artery, terminal part of internal carotid artery, middle third of the intradural part of vertebral artery and middle third of basilar artery.


Secondary Outcome Measures :
  1. Change of mean transition time (MTT) on perfusion computed tomography. [ Time Frame: Indicators will be measured 1 hour after the BSG ]
    Measurement will be mede with perfusion computed tomography done after one side BSG (left or right, depending of the side of ICP electrode position). Comparation will be made between left and right hemisphere. Measures will be expressed seconds.

  2. Change of regional cerebral blood flow (rCBF) on perfusion computed tomography. [ Time Frame: Measurement will be measured 1 hour after the BSG ]
    Measurement will be mede with perfusion computed tomography done after one side BSG (left or right, depending of the side of ICP electrode position). Comparation will be made between left and right hemisphere. Measures will be expressed ml/100g brain tissue/min.

  3. Change of regional cerebral blood volume (rCBV) on perfusion computed tomography. [ Time Frame: Measurement will be measured 1 hour after the BSG ]
    Measurement will be mede with perfusion computed tomography done after one side BSG (left or right, depending of the side of ICP electrode position). Comparation will be made between left and right hemisphere. Measures will be expressed ml/100g brain tissue.

  4. Change of systolic velocity (sV) on transcranial Doppler ultrasound [ Time Frame: Measurement will be made one hour before and one hour after the BSG. ]
    With transcranial Doppler measurement of systolic velocity (sV) will be made on middle cerebral artery and expressed in cm/s.

  5. Change of diastolic velocity (dV) on transcranial Doppler ultrasound [ Time Frame: Measurement will be made one hour before and one hour after the BSG. ]
    With transcranial Doppler measurement of diastolic velocity (dV) will be made on middle cerebral artery and expressed in cm/s.

  6. Change of pulsatiloty index on transcranial Doppler ultrasound [ Time Frame: Measurement will be made one hour before and one hour after the BSG. ]
    With transcranial Doppler measurement of pulsatility index will be made on middle cerebral artery.

  7. Change of the brain tissue oxygenation. [ Time Frame: Measurements will be made before and 5, 10, 15, 20, 25, 30 minutes after the BSG. ]
    Brain tissue oxygenation will be measured with near infrared spectroscopy (NIRS) on both sides of the head.

  8. Change of the ICP. [ Time Frame: Measurement will be done before and every minute in the next 12 hours after the BSG. ]
    Intracranial pressure will be measured with the intracranial pressure electrode in mmHg.

  9. Change in concentration of plasma interleucin 6 (IL-6). [ Time Frame: Blood samples will be taken 1 hour before BSG. Next samples 1, 6, 12, 24 hours after the BSG. ]
    The investigators will measure plasma interleucin 6 (IL-6) in micrograms/mL. Blood samples will be taken from arterial line and right deep jugular vein.

  10. Change in concentration of plasma protein S100B (S100B). [ Time Frame: Blood samples will be taken 1 hour before BSG. Next samples 1, 6, 12, 24 hours after the BSG. ]
    The investigators will measure plasma protein S100B in mcg/L. Blood samples will be taken from arterial line and right deep jugular vein.

  11. Change in concentration of plasma neuron specific enolase (NSE). [ Time Frame: Blood samples will be taken 1 hour before BSG. Next samples 1, 6, 12, 24 hours after the BSG. ]
    The investigators will measure plasma neuron specific enolase (NSE) in micrograms/L. Blood samples will be taken from arterial line and right deep jugular vein.

  12. Change in concentration of plasma glial fibrillary acidic protein (GFAP). [ Time Frame: Blood samples will be taken 1 hour before BSG. Next samples 1, 6, 12, 24 hours after the BSG. ]
    The investigators will measure plasma glial fibrillary acidic protein (GFAP) in micrograms/L. Blood samples will be taken from arterial line and right deep jugular vein.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with moderate and severe head injury
  • patients who underwent computed tomograply angiography of the brain (CTA) at admission to the UKC Ljubljana Emergency Center or during CIT treatment
  • patients with intra-parenchymal intracranial pressure monitor electrode (ICP) installed

Exclusion Criteria:

  • patients with primary decompression craniectomy
  • radiological signs of progression of intracranial hematomas
  • barbiturate coma
  • patients with a norepinephrine dose greater than 0.2 mcg/kg/min
  • pregnant women
  • children
  • known hypersensitivity to iodine contrast media and local anesthetics
  • poor renal function (estimated glomerular filtration below 30ml / min / 1.73m2).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04208477


Contacts
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Contact: Ivan Kostadinov 0038641962566 ivankostadinov@live.com
Contact: Primoz Gradisek primoz.gradisek@kclj.si

Sponsors and Collaborators
University Medical Centre Ljubljana
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Responsible Party: Ivan Kostadinov, asist Ivan Kostadinov, dr.med.EDRA, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT04208477    
Other Study ID Numbers: UMCLjubljana Stellate
First Posted: December 23, 2019    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 2 years

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ivan Kostadinov, University Medical Centre Ljubljana:
stellate ganglion block
brain hemodynamics
brain inflammatory response
Additional relevant MeSH terms:
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Ganglion Cysts
Brain Injuries
Brain Injuries, Traumatic
Vasospasm, Intracranial
Encephalitis
Inflammation
Wounds and Injuries
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Cysts
Neoplasms
Mucinoses
Connective Tissue Diseases
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases