NCT07844811Completed
Early Redox Biomarker Changes After Stellate Ganglion Block in Traumatic Brain Injury
Early Redox Biomarker Changes After Stellate Ganglion Block in Traumatic Brain Injury: A Paired Arterial-Jugular Pilot Study
Source: ClinicalTrials.gov · Last updated 1 Oct 2026
Brief summary (registry, in English)
Oxidative stress is a key mediator of secondary brain injury after traumatic brain injury (TBI). The stellate ganglion block (SGB) has been shown to modulate cerebral hemodynamics and neuroinflammation in brain-injured patients, but its effect on circulating redox biomarkers in human TBI has not been studied. This is a post hoc secondary analysis of stored paired arterial and internal jugular venous blood samples from a prospective, single-center, before-and-after pilot study conducted at the University Medical Centre Ljubljana (parent trial: NCT04208477). Twenty adult patients with moderate-to-severe TBI (Glasgow Coma Scale score 12 or lower before intubation) who received a single ultrasound-guided SGB were included. Paired blood samples collected at baseline and at 12 and 24 hours after SGB were assayed for derivatives of reactive oxygen metabolites (d-ROMs), plasma antioxidant capacity (PAT), the composite oxidative stress index (OSI = d-ROMs/PAT), the early lipid-peroxidation marker hexanoyl-lysine (HEL), and the oxidative DNA-damage marker 8-hydroxy-2'-deoxyguanosine (8-OHdG). No new intervention was administered, no additional patients were enrolled, and no additional biological samples were collected. The primary outcome is the within-participant change in jugular venous OSI from baseline to 12 hours after SGB. Secondary outcomes include temporal changes in d-ROMs, HEL, and 8-OHdG in both arterial and jugular venous compartments, and the interaction between blood compartment and time. The statistical analysis plan for the oxidative-stress endpoints was documented before the biomarker assays were performed. This pilot study provides variability estimates and preliminary data to inform the design of future controlled trials evaluating SGB as a potential modulator of post-traumatic oxidative stress.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 20 (actual)
- First submitted
- 18 Sept 2026
- Start date
- 1 Nov 2021
- Primary completion date
- 31 Dec 2023
- Lead sponsor
- University Medical Centre Ljubljana
- NCT number
- NCT07844811
What you commit to
- Study type: Observational
- Participants enrolled: 20
- From 1 Nov 2021 to the primary completion date, 31 Dec 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Samples failing prespecified laboratory quality-control criteria.
Other
- Absence of a baseline paired arterial and jugular venous blood sample.
- Absence of suitable post-block samples required for the longitudinal analysis. Insufficient sample volume or sample quality for the planned redox biomarker analyses.
- Incomplete or inconsistent sample identification or collection-time data preventing reliable pairing of arterial and jugular venous samples.
- Withdrawal of consent or absence of authorization for secondary analysis of stored samples.
Who the study is looking for
- Adult patients with moderate or severe traumatic brain injury who participated in the original stellate ganglion block study (NCT04208477).
- Glasgow Coma Scale score of 12 or lower before tracheal intubation.
- Receipt of a single ultrasound-guided stellate ganglion block during the original study.
- Availability of stored paired arterial and jugular venous blood samples collected at baseline and at the required post-block time points.
- Availability of sufficient clinical and laboratory data to link the paired samples and determine their collection time relative to the stellate ganglion block.
- Original informed consent provided by the participant's legally authorized representative permitted storage and subsequent scientific analysis of the collected samples.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Medical Centre Ljubljana (UMCL) Coordinator of this site? Confirm its status | Ljubljana | Slovenia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.