Registry AutoLog Lipid Removal and Blood Component Characterization
|ClinicalTrials.gov Identifier: NCT01565967|
Recruitment Status : Completed
First Posted : March 29, 2012
Last Update Posted : October 29, 2015
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.
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||199 participants|
|Official Title:||Registry AutoLog Lipid Removal and Blood Component Characterization|
|Study Start Date :||December 2011|
|Primary Completion Date :||March 2013|
|Study Completion Date :||March 2013|
All patients undergoing surgery which requires routine use of an autotransfusion system
- level of reduction of nonemulsified fat [ Time Frame: after process ]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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|