Registry AutoLog Lipid Removal and Blood Component Characterization
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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|
|Actual Primary Completion Date :||March 2013|
|Actual 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|