Registry AutoLog Lipid Removal and Blood Component Characterization

Trauma Clinical Trial

Official title:

Registry AutoLog Lipid Removal and Blood Component Characterization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01565967
• Other study ID #: AutoLog
• Status: Completed
• Phase: N/A
• First received: June 8, 2011
• Last updated: October 28, 2015
• Start date: December 2011
• Est. completion date: March 2013

Study information

• Verified date: October 2015
• Source: Medtronic Cardiovascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Luxembourg: Ministère de la Santé
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Trauma

Locations

Country	Name	City	State
Italy	Azienda Ospedaliera Universitaria Materdomini	Catanzaro
Lithuania	Vilnius University Hospital Santariskiu Klinikos	Vilnius
Luxembourg	Institut national de chirurgie cardiaque et de cardiologie interventionnelle (INCCI)	Luxembourg
Netherlands	VU Medisch Centrum	Amsterdam
South Africa	Zuid-Afrikaans Hospital	Pretoria
Sweden	Universitetssjukhuset i Lund	Lund

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Bakken Research Center

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No