Registry AutoLog Lipid Removal and Blood Component Characterization

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.

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