Euthyroid Sick Syndrome (ESS) Effect on Traumatic Brain Injury Patients and Its Relation With GFA… (NCT04806672) | Clinical Trial Compass
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Euthyroid Sick Syndrome (ESS) Effect on Traumatic Brain Injury Patients and Its Relation With GFAP Level
50 participantsStarted 2022-09-01
Plain-language summary
Euthyroid sick syndrome (ESS) effects on patients suffering from traumatic brain injury (TBI) have received little attention. Moreover, there is limited evidence that serum levels of thyroid-related hormones might influence functional outcome in the acute phase of brain damage. However, the relationship is complex, and the relevance for functional outcome and the question of therapeutic interventions remain the subject of ongoing researches .
Historically, a wide range of brain damage markers have been examined in TBI patients. However, owing to the limited tissue specificity and other concerns, most markers, including neuro-specific enolase and S100B protein, were compromised in routine clinical use .
Glial fibrillary acidic protein (GFAP) was recently reported to have greater prognostic value than other biomarkers in TBI patients as a monomeric intermediate filament protein concentrated in the astroglial cytoskeleton; GFAP is specific to brain tissue and is not routinely found in peripheral blood circulation. However, GFAP is released after astrocyte death, making it an ideal candidate marker for brain injury patients . Several studies have found that the serum levels of GFAP on admission were significantly increased in TBI patients, also a correlation between serum concentrations and the pathological types of brain damage and clinical outcomes were also reported . However, the changes in serum GFAP over time and the associated predictive utility over the acute days post injury are largely unknown.
To study the hypothesis of euthyroid sick syndrome (ESS) traumatic brain injury patients and its relation with GFAP.
Who can participate
Age range
18 Years – 60 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:
* Age : between (18-60) years old.
* Gender : both males and females.
* Isolated moderate to severe traumatic brain injury(TBI) GCS (3-12) who is expected to survive for more than 24 hours
Exclusion Criteria:
* Poly trauma patients.
* Critically ill patients.
* Patients with history of endocrinal disturbance involving both hypothalamo-pituitary axis and thyroid gland.
* Patients receiving antithyroid medication or hormonal replacement like thyroxin and insulin.
* Pregnant and lactating females.
* Patients with history neurological or psychiatric disorders.
* Patients with liver or renal failure.
* Patients with recent use of amiodarone or β-blockers.
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.
1This study is looking at euthyroid sick syndrome in traumatic brain injury patients — could you explain what euthyroid sick syndrome is and whether it's something that would be checked and monitored in my or my loved one's care right now?
2The trial is measuring GFAP levels alongside thyroid function — what is GFAP, and can you tell me whether tracking this protein would give us useful information about the severity or progression of the brain injury?
3Since this study appears to be observational and is measuring incidence, morbidity, and mortality rather than testing a specific treatment, does participating mean any changes to the care being received, or is it purely a matter of having additional tests or data collected?
4The recruitment status for this trial is listed as unknown — do you know whether this study is still actively enrolling patients, and if not, are there similar studies looking at thyroid function and brain injury outcomes that might be available to us?
5If euthyroid sick syndrome does develop during recovery from a traumatic brain injury, is there any established standard of care for managing it, and how might being in this study help inform decisions about treatment?
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.