Early Redox Biomarker Changes After Stellate Ganglion Block in Traumatic Brain Injury

NCT07844811 | Completed

• 2 other identifiers: Oxidative Stress0120-537/2019/15
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Brain Injuries, Traumatic

Keywords

Stellate ganglion block; Moderate and severe traumatic brain injury; Neuroinflammation; Oxidative stress; Redox biomarkers; Brain injury biomarkers; Autonomic neuromodulation

Outcome Measures

Primary Outcomes (1)

• Change in Oxidative Stress Index in Paired Arterial and Jugular Venous Blood Samples

  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.

  Baseline, 12 hours, and 24 hours after stellate ganglion block

Secondary Outcomes (4)

• Change in Derivatives of Reactive Oxygen Metabolites

  Baseline, 12 hours, and 24 hours after stellate ganglion block

• Change in Hexanoyl-Lysine Concentration

  Baseline, 12 hours, and 24 hours after stellate ganglion block

• Change in 8-Hydroxy-2'-Deoxyguanosine Concentration

  Baseline, 12 hours, and 24 hours after stellate ganglion block

• Change in plasma antioxidant capacity

  Baseline, 12 hours, and 24 hours after stellate ganglion block

Other Outcomes (1)

• Concentration of inflammatory and brain-injury biomarkers

  Baseline, 12 hours, and 24 hours after stellate ganglion block

Study Arms (1)

Patients With Traumatic Brain Injury Previously Treated With Stellate Ganglion Block

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.

Other: Ultrasound-guided stellate ganglion block (parent study)

Interventions

Ultrasound-guided stellate ganglion block (parent study) OTHER

Single ultrasound-guided left stellate ganglion block with local anesthetic, administered as part of the parent interventional study (NCT04208477). No additional intervention was performed for this secondary analysis.

Patients With Traumatic Brain Injury Previously Treated With Stellate Ganglion Block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of 20 adult patients with moderate or severe traumatic brain injury who were treated in the surgical intensive care unit of the University Medical Centre Ljubljana and participated in the original stellate ganglion block study (NCT04208477). All patients had a Glasgow Coma Scale score of 12 or lower before intubation and received a single ultrasound-guided stellate ganglion block. This retrospective post hoc study analyzes stored paired arterial and jugular venous blood samples collected at baseline and 12 and 24 hours after the block. No new participants were enrolled, no additional intervention was administered, and no additional biological samples were collected for this analysis.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Medical Centre Ljubljana: lead

Study Sites (1)

University Medical Centre Ljubljana (UMCL)

Ljubljana, 1000, Slovenia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Stored paired arterial and jugular venous plasma samples collected during the parent study (NCT04208477).

MeSH Terms

Conditions

Brain Injuries, Traumatic; Lymphoma, Follicular; Neuroinflammatory Diseases

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 18, 2026
• First Posted: September 28, 2026
• Study Start: November 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: May 1, 2026
• Last Updated: October 1, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: Data will be available beginning after publication of the study results and for 5 years thereafter.
• Access Criteria: Data will be available to qualified researchers who submit a methodologically sound proposal to the corresponding author. Access will be subject to approval by the study investigators and institutional data controller, compliance with applicable ethical and data-protection requirements, and completion of a data-use agreement. Data may be used only for the purposes specified in the approved proposal.

Locations

SL (1)