The Exploratory Study About the Effect of Using Double Filtration Plasmapheresis (DFPP) Removing Inflammatory Cytokines, Lipids and Toxic Metal Ions in Peripheral Blood in Adults
1 other identifier
interventional
250
1 country
1
Brief Summary
This study investigates whether using Double Filtration Plasmapheresis (DFPP) could improve the overall health of adults through removing inflammatory cytokines, lipids and toxic metal ions from peripheral blood. It's also postulated that DFPP could boost immune cells through removing certain inflammatory cytokines and blood lipids.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2024
CompletedFirst Posted
Study publicly available on registry
January 25, 2024
CompletedStudy Start
First participant enrolled
March 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2025
CompletedJanuary 25, 2024
January 1, 2024
10 months
January 16, 2024
January 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Inflammatory cytokine panel
IL-2,IL-4,IL-6,IL-10, TNF-a, IFN-r, hs CRP(subjected to change)
Baseline, day0, 1, 3, 6 month after DFPP
Blood lipid panel
Total cholesterol, total triglycerides, low-density lipoprotein(LDL), high-density lipoprotein(HDL), lipoprotein(a)(subjected to change)
Baseline, day0, 1, 3, 6 month after DFPP
Toxic metal ions
Lead, mercury etc based on the specific exposure
Baseline, day0
Secondary Outcomes (1)
Immune cells
Baseline, day0, 1, 3, 6 month after DFPP
Study Arms (3)
Group A: Inflammatory cytokine group
EXPERIMENTALSelf-control
Group B: Lipid group
EXPERIMENTALSelf-control
Group C: Toxic metal ions group
EXPERIMENTALSelf-control
Interventions
One session of blood purification using DFPP to remove inflammatory cytokines in peripheral blood.
Eligibility Criteria
You may qualify if:
- Male/females of 18 to 85 years of age. For Group B, subjects should have elevated blood lipid or cholesterol, which could be a. hyperlipidemia; b. higher than the normal range but not high enough to be diagnosed as hyperlipidemia. Able to provide written Informed Consent. Able to follow verbal and written study directions.
You may not qualify if:
- Have sever liver and kidney dysfunction. Have cardiopulmonary insufficiency. Have solid or blood tumor. Pregnancy or breastfeeding women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shanghai Mengchao Cancer Hospital
Shanghai, Shanghai Municipality, 200240, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2024
First Posted
January 25, 2024
Study Start
March 1, 2024
Primary Completion
December 31, 2024
Study Completion
March 1, 2025
Last Updated
January 25, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share