Registry AutoLog Lipid Removal and Blood Component Charac... | NCT01565967

Studies
Registry AutoLog Lipid Removal and Blood Component Characterization

NCT01565967

Sponsor

Medtronic Cardiac Rhythm and Heart Failure

Status

Completed

Last Update Posted

Oct 29, 2015Estimated

Enrollment

199Actual

Phase

Not provided

Conditions

Trauma

Interventions

Not provided

Countries

Italy
Lithuania
Luxembourg
Netherlands
South Africa
Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2011

Primary Completion Date

Mar 2013Actual

Completion Date

Mar 2013Actual

First Submitted Date

Jun 8, 2011

First Submission Date that Met QC Criteria

Mar 28, 2012

First Posted Date

Mar 29, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 28, 2015

Last Update Posted Date

Oct 29, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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:

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

199Actual

Label	Type	Description	Intervention Names
Autotransfusion		All patients undergoing surgery which requires routine use of an autotransfusion system

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Azienda Ospedaliera Universitaria Materdomini		Catanzaro		88100	Italy
Vilnius University Hospital Santariskiu Klinikos