Remove LPS Registry

NCT ID: NCT05260099

Last Updated: 2022-12-20

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-30
• Study Completion Date: 2023-07-31

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.

Conditions

Suspected or Diagnosed Endotoxemia Casued by Gram-negative Bacteria

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: OTHER

Study Groups

Retrospective

Patients not treated with LPS Adsorber

No interventions assigned to this group

Prospective

Patients treated with LPS Adsorber

LPS Adsorber

Intervention Type: DEVICE

LPS Adsorber, binding endotoxin caused by suspected or verified gram-negative bacteria.

Interventions

LPS Adsorber

LPS Adsorber, binding endotoxin caused by suspected or verified gram-negative bacteria.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Weight > 30 kilos

Specific sub-registry criteria are possible.

Exclusion Criteria

• None

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alteco Medical AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Remove LPS Registry

Identifier Type: -

Identifier Source: org_study_id