Clinical trial NCT01565967: Registry AutoLog Lipid Removal and Blood Component Characterization
Official title: Registry AutoLog Lipid Removal and Blood Component Characterization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma
Keywords: AutoLog
Post market release
Non-interventional
Lead sponsor: Medtronic Cardiovascular
Sponsor class: INDUSTRY
First posted: 2012-03-29
Enrollment: 199
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: level of reduction of nonemulsified fat
timeFrame: after process
Secondary outcomes:
Other outcomes:
Locations:
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera Universitaria Materdomini
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santariskiu Klinikos
city: Luxembourg
country: Luxembourg
facility: Institut national de chirurgie cardiaque et de cardiologie interventionnelle (INCCI)
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum
city: Pretoria
country: South Africa
facility: Zuid-Afrikaans Hospital
city: Lund
country: Sweden
facility: Universitetssjukhuset i Lund
Study officials:
References: