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Cannulation of the Artery Axiliaris for Extracorporeal Circulation

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2014 by Johann Wolfgang Goethe University Hospital.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
Pitzer Stiftung
Information provided by (Responsible Party):
Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01615172
First received: June 4, 2012
Last updated: August 5, 2014
Last verified: August 2014
  Purpose
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.

Condition Intervention
Neurologic Manifestations
Procedure: cannulation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cannulation of the Artery Axiliaris for Extracorporeal Circulation

Further study details as provided by Johann Wolfgang Goethe University Hospital:

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 [ Time Frame: Participants will be followed for the duration of hospital stay (5 POD) and a follow up visit 3 months after discharge ] [ Designated as safety issue: Yes ]
    Neurological events were detected by:NIRO (Near-infrared spectroscopy), EEG (Electrencenphalographie), MRI (Magnet resonance imaging) and test battery (Mini mental status test, HAWIE-R)


Estimated Enrollment: 120
Study Start Date: January 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: MAQUET 20, 22 and 24 Fr

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Stenosis of a.subclavia
  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: NCT01615172

Locations
Germany
Goethe Universität
Frankfurt, Hessen, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Pitzer Stiftung
Investigators
Principal Investigator: Andreas Zierer, PD.Dr Goethe University
  More Information

Responsible Party: Arndt-H. Kiessling, Cardia vascular research, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT01615172     History of Changes
Other Study ID Numbers: AXI-001 
Study First Received: June 4, 2012
Last Updated: August 5, 2014
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on December 07, 2016