Registry AutoLog Lipid Removal and Blood Component Characterization

October 28, 2015 updated by: Medtronic Bakken Research Center

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

199

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Catanzaro, Italy, 88100
        • Azienda Ospedaliera Universitaria MaterDomini
  • Lithuania
      • Vilnius, Lithuania, 08861
        • Vilnius University Hospital Santariskiu Klinikos
  • Luxembourg
      • Luxembourg, Luxembourg, 1210
        • Institut national de chirurgie cardiaque et de cardiologie interventionnelle (INCCI)
  • Netherlands
      • Amsterdam, Netherlands, 1007MB
        • VU Medisch Centrum
  • South Africa
      • Pretoria, South Africa, 0002
        • Zuid-Afrikaans Hospital
  • Sweden
      • Lund, Sweden, 22185
        • Universitetssjukhuset i Lund

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Autotransfusion
All patients undergoing surgery which requires routine use of an autotransfusion system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
level of reduction of nonemulsified fat
Time Frame: after process
The primary endpoint of this study is the level of reduction of nonemulsified fat after processing through the Medtronic AutoLog.
after process

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Bakken Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

June 8, 2011

First Submitted That Met QC Criteria

March 28, 2012

First Posted (Estimate)

March 29, 2012

Study Record Updates

Last Update Posted (Estimate)

October 29, 2015

Last Update Submitted That Met QC Criteria

October 28, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AutoLog

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Trauma

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe