NCT07865585|Not Yet RecruitingDMC
HOPE-Sepsis: Hemoadsorption Therapy for Sepsis
Proteomic Analysis and Clinical Efficacy Evaluation of Hemoadsorption Therapy in Sepsis
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Proteomic Analysis and Clinical Efficacy Evaluation of Hemoadsorption Therapy in Sepsis
Sponsor study identifier
interventional
30
1 country
1
Study Start
October 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This is a single-center, prospective, single-arm, open-label study that will enroll 30 adult patients with sepsis at Zhongshan Hospital, Fudan University. All participants will receive CA330 hemoadsorption in addition to standard care. Blood samples will be collected at prespecified time points before hemoadsorption (T0), immediately after completion of hemoadsorption (T1), and approximately 24 hours after completion of hemoadsorption (T2) to evaluate changes in IL-6 and other inflammatory biomarkers. TMT-based quantitative proteomics will be performed on plasma samples collected at T0 and T1 to characterize acute treatment-associated molecular changes and explore their relationships with clinical outcomes.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 17, 2026
Actual (reported)October 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 8, 2026
Actual (reported)December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Immediate change in plasma IL-6 concentration after hemoadsorption
The primary outcome is the immediate change in plasma IL-6 concentration from the pre-hemoadsorption baseline (T0) to immediately after completion of hemoadsorption (T1).
Baseline before initiation of hemoadsorption (T0) and immediately after completion of hemoadsorption (T1)
Acute change in plasma proteomic profile after hemoadsorption
Baseline before initiation of hemoadsorption (T0) and immediately after completion of hemoadsorption (T1)
Changes in inflammatory markers
Baseline before hemoadsorption (T0), immediately after completion of hemoadsorption (T1), and approximately 24 hours after treatment (T2)
Change in SOFA score
Baseline, 24 hours, 48 hours, and 7 days after treatment
28 day all-cause mortality
Up to 28 days.
ICU mortality (death before ICU discharge)
From ICU admission to ICU discharge or death, up to 90 days.
Treatment-related adverse events
During treatment and through Day 28 after enrollment (or until hospital discharge, whichever occurs first).
Participants will receive CA330 hemoadsorption in addition to standard care for sepsis. Blood samples will be collected at T0 (before hemoadsorption), T1 (immediately after completion of hemoadsorption), and T2 (24 ±2 hours after treatment) for biomarker assessment. Plasma proteomics will be performed using samples collected at T0 and T1.
Patients will receive hemoadsorption therapy using the Cytokine Adsorption Column CA330 (Jafron Biomedical Co., Ltd., Zhuhai, China). During treatment, whole blood passes through an extracorporeal hemoperfusion circuit containing the adsorption cartridge. Circulating inflammatory mediators are removed by adsorption, and the treated blood is returned directly to the patient. Plasma separation is not performed. CRRT may be administered according to routine clinical indications and is not required for study participation. Standard-of-care therapy for sepsis will be provided throughout the study according to the treating team.Each index hemoadsorption session will last approximately 2-4 hours.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032, China
Ming Zhong, Ph.D
Fudan University
First Submitted
January 17, 2026
First Posted
October 8, 2026
Study Start
October 1, 2026
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 8, 2026
Record last verified: 2026-10
De-identified individual participant data underlying the results reported in the primary publication may be made available upon reasonable request to the principal investigator, subject to institutional policies and applicable ethics requirements.
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Source: ClinicalTrials.gov.
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