Registry AutoLog Lipid Removal and Blood Component Characterization
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:
- to determine the lipid removal capabilities of the Medtronic AutoLog System.
- to obtain in vivo data on blood component removal and washing capabilities of the Medtronic AutoLog System.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Registry AutoLog Lipid Removal and Blood Component Characterization|
- level of reduction of nonemulsified fat [ Time Frame: after process ] [ Designated as safety issue: No ]The primary endpoint of this study is the level of reduction of nonemulsified fat after processing through the Medtronic AutoLog.
Biospecimen Retention: Samples With DNA
Whole blood and washed blood will be collected from each patient
|Study Start Date:||December 2011|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
All patients undergoing surgery which requires routine use of an autotransfusion system
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01565967
|Azienda Ospedaliera Universitaria Materdomini|
|Catanzaro, Italy, 88100|
|Vilnius University Hospital Santariskiu Klinikos|
|Vilnius, Lithuania, 08861|
|Institut national de chirurgie cardiaque et de cardiologie interventionnelle (INCCI)|
|Luxembourg, Luxembourg, 1210|
|VU Medisch Centrum|
|Amsterdam, Netherlands, 1007MB|
|Pretoria, South Africa, 0002|
|Universitetssjukhuset i Lund|
|Lund, Sweden, 22185|