Cannulation of the Artery Axiliaris for Extracorporeal Circulation

August 5, 2014 updated by: Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

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

  • Germany
    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • Recruiting
        • Goethe Universität
        • Contact:

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

40 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Stenosis of a.subclavia

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Aortic cannulation
routine placement of aortic cannula
Procedure: cannulation
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)
Other Names:
  • MAQUET 20, 22 and 24 Fr
ACTIVE_COMPARATOR: axilaris cannulation
new type of cannulation
Procedure: cannulation
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)
Other Names:
  • MAQUET 20, 22 and 24 Fr

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surrogat endpoint: Number of participants with change from baseline in Neurolocial events at 5th postoperative day (POD) and 3 month after operation
Time Frame: Participants will be followed for the duration of hospital stay (5 POD) and a follow up visit 3 months after discharge
Neurological events were detected by:NIRO (Near-infrared spectroscopy), EEG (Electrencenphalographie), MRI (Magnet resonance imaging) and test battery (Mini mental status test, HAWIE-R)
Participants will be followed for the duration of hospital stay (5 POD) and a follow up visit 3 months after discharge

Collaborators and Investigators

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

Sponsor

Johann Wolfgang Goethe University Hospital

Collaborators

Pitzer Stiftung

Investigators

  • Principal Investigator: Andreas Zierer, PD.Dr, Goethe University

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

January 1, 2011

Primary Completion (ANTICIPATED)

December 1, 2014

Study Completion (ANTICIPATED)

December 1, 2014

Study Registration Dates

First Submitted

June 4, 2012

First Submitted That Met QC Criteria

June 6, 2012

First Posted (ESTIMATE)

June 8, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 6, 2014

Last Update Submitted That Met QC Criteria

August 5, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AXI-001

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.

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