Registry AutoLog Lipid Removal and Blood Component Characterization

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Medtronic Bakken Research Center
ClinicalTrials.gov Identifier:
NCT01565967
First received: June 8, 2011
Last updated: March 23, 2013
Last verified: March 2013
  Purpose

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.

Condition
Trauma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Registry AutoLog Lipid Removal and Blood Component Characterization

Further study details as provided by Medtronic Bakken Research Center:

Primary Outcome Measures:
  • level of reduction of nonemulsified fat [ Time Frame: after process ] [ Designated as safety issue: No ]
    The primary endpoint of this study is the level of reduction of nonemulsified fat after processing through the Medtronic AutoLog.


Biospecimen Retention:   Samples With DNA

Whole blood and washed blood will be collected from each patient


Enrollment: 199
Study Start Date: December 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Autotransfusion
All patients undergoing surgery which requires routine use of an autotransfusion 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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01565967

Locations
Italy
Azienda Ospedaliera Universitaria Materdomini
Catanzaro, Italy, 88100
Lithuania
Vilnius University Hospital Santariskiu Klinikos
Vilnius, Lithuania, 08861
Luxembourg
Institut national de chirurgie cardiaque et de cardiologie interventionnelle (INCCI)
Luxembourg, Luxembourg, 1210
Netherlands
VU Medisch Centrum
Amsterdam, Netherlands, 1007MB
South Africa
Zuid-Afrikaans Hospital
Pretoria, South Africa, 0002
Sweden
Universitetssjukhuset i Lund
Lund, Sweden, 22185
Sponsors and Collaborators
Medtronic Bakken Research Center
  More Information

No publications provided

Responsible Party: Medtronic Bakken Research Center
ClinicalTrials.gov Identifier: NCT01565967     History of Changes
Other Study ID Numbers: AutoLog
Study First Received: June 8, 2011
Last Updated: March 23, 2013
Health Authority: Luxembourg: Ministère de la Santé

Keywords provided by Medtronic Bakken Research Center:
AutoLog
Post market release
Non-interventional

ClinicalTrials.gov processed this record on September 16, 2014