Registry AutoLog Lipid Removal and Blood Component Characterization

NCT ID: NCT01565967

Last Updated: 2015-10-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 199 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2013-03-31

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.

Conditions

Trauma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Autotransfusion

All patients undergoing surgery which requires routine use of an autotransfusion system

No interventions assigned to this group

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

VU Medisch Centrum

Amsterdam, , Netherlands

Zuid-Afrikaans Hospital

Pretoria, , South Africa

Universitetssjukhuset i Lund

Lund, , Sweden

Countries

Italy; Lithuania; Luxembourg; Netherlands; South Africa; Sweden

Other Identifiers

AutoLog

Identifier Type: -

Identifier Source: org_study_id