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L'essai clinique NCT07259668 pour Brûlures est pas encore en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Lipopolysaccharide Adsorption (Efferon LPS) in Patients With Thermal Burns
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L'étude clinique NCT07259668 est un essai observationnel pour Brûlures. Son statut actuel est : pas encore en recrutement. Le recrutement est prévu pour commencer le 8 décembre 2025, avec un objectif de 15 participants. Dirigé par Efferon JSC, l'essai devrait être terminé d'ici le 31 mars 2028. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 2 décembre 2025.
Résumé succinct
This observational pilot study aims to establish criteria for evaluating the effectiveness of hemoadsorption with the Efferon LPS device in adult patients with burn injury. Participants will be prospectively enrolled into the treatment group and compared with a retrospectively selected control group. Each patient in the treatment group will undergo two hemoadsorption sessions, each lasting 6-12 hours, with a 24 hours interval between sessions. The procedures may be performed in combination with hemofiltration or hemodiafiltration at the investigator's discretion.
Description détaillée
Extensive burns represent a severe form of trauma that, according to the World Health Organization, cause more than 180,000 deaths worldwide each year. Despite advances in modern medicine, sepsis and other infectious complications remain leading contributors to mortality among severely burned patients.
The Efferon LPS device, originally developed for sepsis, targets both primary and secondary inflammatory mediators. This technology also shows promise in burn injury, which involves a complex systemic inflammatory response. Burn trauma induces the release of cytokines and damage-associated molecular patterns (DAMPs), while increased intestinal permeability and endotoxin translocation may lead to the appearance of pathogen-associated molecular patterns (PAMPs). Addressing both DAMPs and PAMPs is therefore essential for effective burn injury management. The aim of this study is to identify criteria for evaluating the effectiveness of hemoadsorption with the Efferon LPS device in adult patients with burn injury.
Titre officiel
An Observational Pilot Study Evaluating the Efficacy and Safety of LPS Adsorption Using the Efferon LPS Device in Patients With Thermal Burns
Conditions
BrûluresAutres identifiants de l'essai
- efferon-lps 2025-03.1
Numéro NCT
Date de début (réel)
2025-12-08
Dernière mise à jour publiée
2025-12-02
Date de fin (estimée)
2028-03-31
Inscription (estimée)
15
Type d'essai
Observationnel
Statut
Pas encore en recrutement
Mots clés
Hemoadsorption
Hemoperfusion
Extracorporeal therapy
LPS adsorption
Hemoperfusion
Extracorporeal therapy
LPS adsorption
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
Control group The retrospective control group will include patients from the same medical institution's records from the previous 3 years, matched to the study cohort using propensity score matching. These patients received standard therapy for thermal burns, which could include hemofiltration or hemodiafiltration procedures. | N/A |
Baseline therapy + Efferon LPS Patients will receive standart therapy for thermal burns treatments and Efferon LPS hemoadsorption procedure. Prospective enrollement. | Efferon LPS Efferon LPS, a medical device, which is a single-use cartridge filled with a polymeric adsorbent that selectively adsorbs endotoxin via surface-immobilized ligand and excessive cytokines via its intrinsic porosity. Two hemoadsorption procedures will be performed per patient, with a duration of 6-12 hours each and an interval of 24 hours between procedures. The procedures may be administered in combination with hemofiltration or hemodiafiltration, as determined by the investigator. |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Effect of the Efferon LPS hemoadsoption on ICU length of stay | Time (days) from the start of hemoadsorption to transfer from the ICU | 1-28 days |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Effect of the Efferon LPS hemoadsoption on need for vasopressor support | Need for vasopressors according to the VIS 2020 heart rate scale (Vasoactive inotropic score) | 1-28 days |
Effect of the Efferon LPS hemoadsoption on pulmonary oxygen metabolic function | Value of oxygenation index (Pa02 / Fi02 (Pa)) | 1-28 days |
Effect of the Efferon LPS hemoadsoption on duration of renal replacement therapy (RRT) | Duration of renal replacement therapy (RRT) in hours | 1-28 days |
Effect of the Efferon LPS hemoadsoption on incidence of septic complications | Frequency of septic complications | 1-28 days |
Effect of the Efferon LPS hemoadsoption on frequency of surgical interventions | Frequency of surgical interventions | 1-28 days |
Effect of the Efferon LPS hemoadsoption on 28 days mortality | Mortality rate | 1-28 days |
Effect of the Efferon LPS hemoadsoption on length of hospital stay | Length of hospital stay | 1-60 days |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
- Thermal burn of Ⅱ and Ⅲ severity with a lesion area of 40% or more (ICD-10: T20-T25, T29)
- Burn disease in the stage of acute toxemia or septicemia
- Frank Index ≥ 90 (Frank Index quantifies burn severity based on the depth and total surface area of the skin lesion)
- The patient's condition allows for Efferon LPS therapy for at least 6 hours
- Isolated thermal inhalation injury
- Charlson Comorbidity Index > 8
- Dementia
- End-stage renal failure
- Acute pulmonary embolism confirmed by CT
- Acute myocardial infarction within the past 4 weeks
- Acute cerebrovascular accident
- Uncontrolled bleeding (acute blood loss within the past 24 hours)
- Any other condition which, in the opinion of the investigator, makes the patient unsuitable for inclusion in the study
Efferon JSCContact central de l'essai
Contact: Alexandr Shelehov-Kravchenko, PhD, MD, +79636564765, [email protected]
1 Centres de l'essai dans 1 pays
State Novosibirsk Regional Clinical Hospital, Novosibirsk, 630087, Russia
Igor Samatov, PhD, MD, Contact, +79139084409, [email protected]