Registry AutoLog Lipid Removal and Blood Component Characterization

Completed

• Conditions: Trauma

• Registration Number: NCT01565967
• Lead Sponsor: Medtronic Bakken Research Center

Brief 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.

Study Timeline

• Study First Submitted: 2011-06-08
• Study Start: 2011-12
• Study First Submitted QC: 2012-03-28
• Study First Posted: 2012-03-29
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-28
• Last Update Posted: 2015-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
level of reduction of nonemulsified fat	after process	The primary endpoint of this study is the level of reduction of nonemulsified fat after processing through the Medtronic AutoLog.

Trial Locations

Locations (6)

Azienda Ospedaliera Universitaria Materdomini; 🇮🇹 Catanzaro, Italy

Vilnius University Hospital Santariskiu Klinikos; 🇱🇹 Vilnius, Lithuania

Institut national de chirurgie cardiaque et de cardiologie interventionnelle (INCCI); 🇱🇺 Luxembourg, Luxembourg

Zuid-Afrikaans Hospital; 🇿🇦 Pretoria, South Africa

Universitetssjukhuset i Lund; 🇸🇪 Lund, Sweden

VU Medisch Centrum; 🇳🇱 Amsterdam, Netherlands