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RECRUITING
NCT07248930

Lipopolysaccharide Adsorption (Efferon LPS NEO) in Children With Thermal Burns

Sponsor: Efferon JSC

View on ClinicalTrials.gov

Summary

This observational pilot study aims to identify criteria for evaluating the effectiveness of hemoadsorption with the Efferon LPS NEO device in pediatric burn injury. Participants will be prospectively assigned to 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 an interval of 24-120 hours between procedures. The sessions may be performed in combination with hemofiltration or hemodiafiltration at the discretion of the investigator.

Official title: An Observational Pilot Study Evaluating the Efficacy and Safety of LPS Adsorption Using the Efferon LPS NEO Device in Children With Thermal Burns

Key Details

Gender

All

Age Range

1 Year - 14 Years

Study Type

OBSERVATIONAL

Enrollment

30

Start Date

2025-10-01

Completion Date

2027-03-31

Last Updated

2025-11-25

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Efferon LPS NEO

Efferon LPS NEO, a medical device, which is a cylindrical body filled with a polymeric hemosorbent that selectively absorbs LPS and excess cytokines. Two hemoadsorption procedures will be performed per patient, with a duration of 6-12 hours each and an interval of 24-120 hours between procedures. The procedures may be administered in combination with hemofiltration or hemodiafiltration, as determined by the investigator.

Locations (2)

Children's City Clinical Hospital No. 9 named after G.N. Speransky of the Moscow City Health Department

Moscow, Russia

Children's municipal multi-specialty clinical center of high medical technology

Saint Petersburg, Russia