Remove LPS Registry
Withdrawn
- Conditions
- Suspected or Diagnosed Endotoxemia Casued by Gram-negative Bacteria
- Interventions
- Device: LPS Adsorber
- Registration Number
- NCT05260099
- Lead Sponsor
- Alteco Medical AB
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- Weight > 30 kilos
Specific sub-registry criteria are possible.
Exclusion Criteria
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Prospective LPS Adsorber Patients treated with LPS Adsorber
- Primary Outcome Measures
Name Time Method The primary endpoint will be the time needed to achieve patient stabilization from the time of treatment. 30 days
- Secondary Outcome Measures
Name Time Method 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