Registry AutoLog Lipid Removal and Blood Component Characterization

NCT01565967 | Completed

• 1 other identifier: AutoLog
• Study Type: observational
• Target: 199
• Locations: 6 countries
• Sites: 6

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. 1.to determine the lipid removal capabilities of the Medtronic AutoLog System.
2. 2.to obtain in vivo data on blood component removal and washing capabilities of the Medtronic AutoLog System.

Conditions

Trauma

Keywords

AutoLog; Post market release; Non-interventional

Outcome Measures

Primary Outcomes (1)

• level of reduction of nonemulsified fat

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

  after process

Study Arms (1)

Autotransfusion

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The subject population includes all subjects with an indication for cardiac surgery, orthopedic surgery etc. in which the hospital treatment protocol requires the routine use of an autotransfusion system, and who meet the inclusion and exclusion criteria.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Cardiac Rhythm and Heart Failure: lead

Study Sites (6)

Azienda Ospedaliera Universitaria Materdomini

Catanzaro, 88100, Italy

Location

Vilnius University Hospital Santariskiu Klinikos

Vilnius, 08861, Lithuania

Location

Institut national de chirurgie cardiaque et de cardiologie interventionnelle (INCCI)

Luxembourg, 1210, Luxembourg

Location

VU Medisch Centrum

Amsterdam, 1007MB, Netherlands

Location

Zuid-Afrikaans Hospital

Pretoria, 0002, South Africa

Location

Universitetssjukhuset i Lund

Lund, 22185, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and washed blood will be collected from each patient

MeSH Terms

Conditions

Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2011
• First Posted: March 29, 2012
• Study Start: December 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: October 29, 2015

Record last verified: 2015-10

Locations

ZA (1); LI (1); LU (1); SE (1); IT (1); NL (1)