Study Stopped
Company decision not to start study
Remove LPS Registry
Post Market Clinical Follow up (PMCF) Medical Device (MD) Registry of the Alteco® LPS Adsorber to Remove Lipopolysaccharide (LPS) in Patients With Suspected Endotoxemia, With Severe Symptom(s)/Complication(s) and Their Stabilization Outcomes: REMOVE LPS Registry
1 other identifier
observational
N/A
0 countries
N/A
Brief Summary
This registry will collect and validate regulatory-grade real-world data (RWD) on the usage of the LPS-Adsorber and the outcomes from using the LPS-Adsorber in various patient populations (various sub-registries) that also have suspected endotoxemia. This data can be then used in real-world evidence (RWE) generation. It will also create reusable infrastructure to allow creation or affiliation with many additional RWD/RWE efforts both prospective and retrospective in nature.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2022
Shorter than P25 for all trials
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
February 18, 2022
CompletedFirst Posted
Study publicly available on registry
March 2, 2022
CompletedStudy Start
First participant enrolled
November 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2023
CompletedDecember 20, 2022
December 1, 2022
Same day
February 18, 2022
December 16, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
The primary endpoint will be the time needed to achieve patient stabilization from the time of treatment.
30 days
Secondary Outcomes (2)
Secondary Outcomes will be to document the change in a patient's symptoms of infection over time.
30 days
Rate of complaints and incidents related to the medical device during the whole registry.
30 days
Study Arms (2)
Retrospective
Patients not treated with LPS Adsorber
Prospective
Patients treated with LPS Adsorber
Interventions
LPS Adsorber, binding endotoxin caused by suspected or verified gram-negative bacteria.
Eligibility Criteria
Patients with suspected or diagnosed sepsis caused by gram-negative bacteria.
You may qualify if:
- Weight \> 30 kilos
- Specific sub-registry criteria are possible.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Target Duration
- 30 Days
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 18, 2022
First Posted
March 2, 2022
Study Start
November 1, 2022
Primary Completion
November 1, 2022
Study Completion
July 1, 2023
Last Updated
December 20, 2022
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share