NCT07259668 Lipopolysaccharide Adsorption (Efferon LPS) in Patients With Thermal Burns
| NCT ID | NCT07259668 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Efferon JSC |
| Condition | Burns |
| Study Type | OBSERVATIONAL |
| Enrollment | 15 participants |
| Start Date | 2025-12-08 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 15 participants in total. It began in 2025-12-08 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Contact & Investigator
Igor Samatov, PhD, MD
PRINCIPAL INVESTIGATOR
State Novosibirsk Regional Clinical Hospital
Frequently Asked Questions
Who can join the NCT07259668 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Burns. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07259668 currently recruiting?
Yes, NCT07259668 is actively recruiting participants. Contact the research team at alexandr.shelehov@gmail.com for enrollment information.
Where is the NCT07259668 trial being conducted?
This trial is being conducted at Novosibirsk, Russia.
Who is sponsoring the NCT07259668 clinical trial?
NCT07259668 is sponsored by Efferon JSC. The principal investigator is Igor Samatov, PhD, MD at State Novosibirsk Regional Clinical Hospital. The trial plans to enroll 15 participants.