Registry AutoLog Lipid Removal and Blood Component Characterization

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01565967

Enrollment

199

Registered

2012-03-29

Start date

2011-12-31

Completion date

2013-03-31

Last updated

2015-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trauma

Keywords

AutoLog, Post market release, Non-interventional

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Italy, Lithuania, Luxembourg, Netherlands, South Africa, Sweden

Outcome results