TraumaNCT01565967
Registry AutoLog Lipid Removal and Blood Component Characterization
An observational study of Trauma, run by Medtronic Cardiac Rhythm and Heart Failure at 6 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Trauma
- How many people
- 199 participants
- Where
- 6 sitesin 6 countries
- Study dates
- Dec 2011to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
Lithuania1 site
Vilnius University Hospital Santariskiu Klinikos
Vilnius, 08861
Luxembourg1 site
Institut national de chirurgie cardiaque et de cardiologie interventionnelle (INCCI)
Luxembourg, 1210
About this study
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:
- to determine the lipid removal capabilities of the Medtronic AutoLog System.
- to obtain in vivo data on blood component removal and washing capabilities of the Medtronic AutoLog System.
Read the 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.
- Conditions
- Trauma
- Keywords
- AutoLog, Post market release, Non-interventional
- Medical subject headings
- Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Autotransfusion | All patients undergoing surgery which requires routine use of an autotransfusion system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: after process
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startDec 2011
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by Medtronic Cardiac Rhythm and Heart FailureThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart Failure
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01565967
- Sponsor's protocol ID
- AutoLog
- Status last verified
- Oct 2015
- First submitted
- 8 Jun 2011
- Last updated
- 29 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry AutoLog Lipid Removal and Blood Component Characterization
- ClinicalTrials.gov ID
- NCT01565967
- Acronym / sponsor ID
- AutoLog
- Conditions
- Trauma
- Keywords
- AutoLog, Post market release, Non-interventional
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Medtronic Cardiac Rhythm and Heart FailureIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 29 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- to determine the lipid removal capabilities of the Medtronic AutoLog System.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autotransfusion | – | –All patients undergoing surgery which requires routine use of an autotransfusion system |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma, run by Medtronic Cardiac Rhythm and Heart Failure at 6 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Italy, Lithuania, Luxembourg, Netherlands, South Africa and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
level of reduction of nonemulsified fat (time frame: after process). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2015.