Lipopolysaccharide Adsorption (Efferon LPS) in Patients With Thermal Burns

NCT07259668 | Recruiting

• 1 other identifier: efferon-lps 2025-03.1
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns

Keywords

Hemoadsorption; Hemoperfusion; Extracorporeal therapy; LPS adsorption

Outcome Measures

Primary Outcomes (1)

• Effect of the Efferon LPS hemoadsorption on ICU length of stay

  Time (days) from the start of hemoadsorption to transfer from the ICU

  1-28 days

Secondary Outcomes (7)

• Effect of the Efferon LPS hemoadsorption on need for vasopressor support

  1-28 days

• Effect of the Efferon LPS hemoadsorption on pulmonary oxygen metabolic function

  1-28 days

• Effect of the Efferon LPS hemoadsorption on duration of renal replacement therapy (RRT)

  1-28 days

• Effect of the Efferon LPS hemoadsorption on incidence of septic complications

  1-28 days

• Effect of the Efferon LPS hemoadsorption on frequency of surgical interventions

  1-28 days

Study Arms (2)

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.

Baseline therapy + Efferon LPS

Patients will receive standard therapy for thermal burns treatments and Efferon LPS hemoadsorption procedure. Prospective enrollment.

Device: Efferon LPS

Interventions

Efferon LPS DEVICE

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.

Baseline therapy + Efferon LPS

Eligibility Criteria

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

Study Population

Adult patients with thermal burns undergoing treatment in State Novosibirsk Regional Clinical Hospital

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Efferon JSC: lead

Study Sites (1)

State Novosibirsk Regional Clinical Hospital

Novosibirsk, 630087, Russia

RECRUITING

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

• Igor Samatov, PhD, MD

  State Novosibirsk Regional Clinical Hospital

  PRINCIPAL INVESTIGATOR

• Alexander Mezhin, PhD, MD

  State Novosibirsk Regional Clinical Hospital

  PRINCIPAL INVESTIGATOR

• Vladimir Kulabukhov, PhD, MD

  NV Sklifosovsky Research Institute for Emergency Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandr Shelehov-Kravchenko, PhD, MD

CONTACT

+79636564765; alexandr.shelehov@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 2, 2025
• Study Start: December 8, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2028
• Last Updated: January 22, 2026

Record last verified: 2026-01

Locations

RU (1)