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Cannulation of the Artery Axiliaris for Extracorporeal Circulation

Primary Purpose

Neurologic Manifestations

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
cannulation
Sponsored by
Johann Wolfgang Goethe University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurologic Manifestations

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Cardiac procedure with ecc Age 40-85 years CABG and/or valve

Exclusion Criteria:

  • Stenosis of a.subclavia

Sites / Locations

  • Goethe UniversitätRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Aortic cannulation

axilaris cannulation

Arm Description

routine placement of aortic cannula

new type of cannulation

Outcomes

Primary Outcome Measures

Surrogat endpoint: Number of participants with change from baseline in Neurolocial events at 5th postoperative day (POD) and 3 month after operation
Neurological events were detected by:NIRO (Near-infrared spectroscopy), EEG (Electrencenphalographie), MRI (Magnet resonance imaging) and test battery (Mini mental status test, HAWIE-R)

Secondary Outcome Measures

Full Information

First Posted
June 4, 2012
Last Updated
August 5, 2014
Sponsor
Johann Wolfgang Goethe University Hospital
Collaborators
Pitzer Stiftung
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1. Study Identification

Unique Protocol Identification Number
NCT01615172
Brief Title
Cannulation of the Artery Axiliaris for Extracorporeal Circulation
Official Title
Cannulation of the Artery Axiliaris for Extracorporeal Circulation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johann Wolfgang Goethe University Hospital
Collaborators
Pitzer Stiftung

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Comparision of two different cannulation techniques on the neurological outcome in cardiac surcical procedures. Study hypothesis: Cannulation of the axilaris artery can reduce neurolocical side effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurologic Manifestations

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aortic cannulation
Arm Type
Active Comparator
Arm Description
routine placement of aortic cannula
Arm Title
axilaris cannulation
Arm Type
Active Comparator
Arm Description
new type of cannulation
Intervention Type
Procedure
Intervention Name(s)
cannulation
Other Intervention Name(s)
MAQUET 20, 22 and 24 Fr
Intervention Description
The different types of cannulation (aortic versus axillaris) were compared in the postoperative period for neurological deficits in three time periods.(intraoperative, 5.POD, 3 month POD)
Primary Outcome Measure Information:
Title
Surrogat endpoint: Number of participants with change from baseline in Neurolocial events at 5th postoperative day (POD) and 3 month after operation
Description
Neurological events were detected by:NIRO (Near-infrared spectroscopy), EEG (Electrencenphalographie), MRI (Magnet resonance imaging) and test battery (Mini mental status test, HAWIE-R)
Time Frame
Participants will be followed for the duration of hospital stay (5 POD) and a follow up visit 3 months after discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cardiac procedure with ecc Age 40-85 years CABG and/or valve Exclusion Criteria: Stenosis of a.subclavia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Zierer, PD.Dr
Organizational Affiliation
Goethe University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Goethe Universität
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Zierer, MD
Phone
+49696301
Ext
0
Email
andreas.zierer@kgu.de
First Name & Middle Initial & Last Name & Degree
Andreas Zierer, MD

12. IPD Sharing Statement

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Cannulation of the Artery Axiliaris for Extracorporeal Circulation

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