Clinical trial · Observational
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
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260929-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Injuries, Traumatic | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ultrasound-guided stellate ganglion block (parent study) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients With Traumatic Brain Injury Previously Treated With Stellate Ganglion Block
- description
- A cohort of adult patients with moderate or severe traumatic brain injury who received an ultrasound-guided stellate ganglion block as part of a previously conducted clinical study. This post hoc study retrospectively analyzes stored paired arterial and jugular venous blood samples collected before and at 12 and 24 hours after the block. No intervention was assigned and no additional samples were collected specifically for the present analysis.
- interventionNames
- Other: Ultrasound-guided stellate ganglion block (parent study)
Primary outcomes (1)
- measure
- Change in Oxidative Stress Index in Paired Arterial and Jugular Venous Blood Samples
- timeFrame
- Baseline, 12 hours, and 24 hours after stellate ganglion block
- description
- Within-participant change from baseline in the oxidative stress index (OSI) measured in paired arterial and jugular venous blood samples at 12 and 24 hours after stellate ganglion block. OSI is a derived measure combining reactive oxygen metabolite levels assessed by the derivatives of reactive oxygen metabolites test (d-ROMs) and antioxidant capacity assessed by the plasma antioxidant test (PAT). Higher OSI values indicate a greater imbalance toward oxidative stress. The analysis evaluates changes over time, differences between arterial and jugular venous compartments, and the interaction between sampling time and blood compartment.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Samples failing prespecified laboratory quality-control criteria. * 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.
References
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