NCT01565967

Registry AutoLog Lipid Removal and Blood Component Characterization

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 199 (actual)
• Sponsor: Medtronic Cardiac Rhythm and Heart Failure · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to show the success of the AutoLog System in removing lipids to less than 10mg/dl in vivo. The Autolog registry has two objectives: 1. to determine the lipid removal capabilities of the Medtronic AutoLog System. 2. to obtain in vivo data on blood component removal and washing capabilities of the Medtronic AutoLog System.

Detailed description

Since the in house data strongly suggest that the Medtronic AutoLog is uniquely high performing in lipid removal in-vitro, the Registry AutoLog Lipid Removal and Blood Component Characterization is initiated to determine if the AutoLog system is successful in removing lipids in vivo as it is in-vitro. Therefore, it is expected that the lipid amounts after washing will be less than 10 mg/dl. The study is designed as a multi-center, non-randomized, non-interventional, post market release study (a registry). The study has a single arm, without controls, as it is descriptive in nature.

Conditions

• Trauma

Timeline

• Start date: 2011-12-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2012-03-29
• Last updated: 2015-10-29

Locations

6 sites across 6 countries: Italy, Lithuania, Luxembourg, Netherlands, South Africa, Sweden