"The Effect of Stellate Ganglion Block in Severe Brain Injury" (NCT04208477) | Clinical Trial Compass
CompletedNot Applicable
"The Effect of Stellate Ganglion Block in Severe Brain Injury"
Slovenia40 participantsStarted 2021-11-01
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in diameter of the cerebral arteries
Timeframe: 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.