NCT07844811Befejeződött
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 1.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 20 (tényleges)
- Első benyújtás
- 2026. szept. 18.
- Kezdés
- 2021. nov. 1.
- Elsődleges befejezés
- 2023. dec. 31.
- Fő szponzor
- University Medical Centre Ljubljana
- NCT-szám
- NCT07844811
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Bevont résztvevők: 20
- 2021. nov. 1. és az elsődleges befejezés (2023. dec. 31.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Laborértékek
- Samples failing prespecified laboratory quality-control criteria.
Egyéb
- 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.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – 80 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| University Medical Centre Ljubljana (UMCL) | Ljubljana | Szlovénia | Ismeretlen állapot |
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