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Completed

NCT Number: NCT01565967

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:

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.

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Key information

Conditions

Trauma Wounds and Injuries

Sex eligibility

All sexes

Study type

Observational

Primary location

Azienda Ospedaliera Universitaria Materdomini, Catanzaro, Italy

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with an indication for surgery procedures in which the hospital treatment protocol requires the routine use of an autotransfusion system are eligible for participation.

Exclusion criteria

  • The use of citrate-based anticoagulant in patients with impaired liver function
  • Gross contamination and/or septic procedures
  • Surgery within the malignant area that may allow dissemination of tumor/malignant cells, if aspirated, into the autotransfusion system
  • Caesarean sections in presence of amniotic fluid
  • Presence of high concentrations of prostatic fluid
  • Contamination of salvaged blood with drugs not intended for intravenous administration
  • Use of collagen-based haemostatic agents and gel foam used in combination with any autotransfusion system
  • Coagulopathy
  • Not willing to sign a Patient Informed Consent/Data Release Form

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Medtronic Cardiac Rhythm and Heart Failure

Industry

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Mar 29, 2012
Registry last updated
Oct 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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