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

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.

Study Overview

• Status: Withdrawn
• Conditions: Suspected or Diagnosed Endotoxemia Casued by Gram-negative Bacteria
• Intervention / Treatment: Device: LPS Adsorber

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with suspected or diagnosed sepsis caused by gram-negative bacteria.

Description

Inclusion Criteria:

• Weight > 30 kilos

Specific sub-registry criteria are possible.

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Retrospective; Patients not treated with LPS Adsorber
Prospective; Patients treated with LPS Adsorber	Device: LPS Adsorber; LPS Adsorber, binding endotoxin caused by suspected or verified gram-negative bacteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The primary endpoint will be the time needed to achieve patient stabilization from the time of treatment.	30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Alteco Medical AB

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2022
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): July 1, 2023

Study Registration Dates

• First Submitted: February 18, 2022
• First Submitted That Met QC Criteria: February 18, 2022
• First Posted (Actual): March 2, 2022

Study Record Updates

• Last Update Posted (Estimate): December 20, 2022
• Last Update Submitted That Met QC Criteria: December 16, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Bacteremia; Toxemia; Endotoxemia
• Other Study ID Numbers: Remove LPS Registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No