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NCT01615172 Clinical Trial

Cannulation of the Artery Axiliaris for Extracorporeal Circulation

Neurologic Manifestations Clinical Trial

Official title:
Cannulation of the Artery Axiliaris for Extracorporeal Circulation

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01615172
Other study ID # AXI-001
Secondary ID
Status Recruiting
Phase N/A
First received June 4, 2012
Last updated August 5, 2014
Start date January 2011
Est. completion date December 2014

Study information
Verified date August 2014
Source Johann Wolfgang Goethe University Hospitals
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 120
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 85 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

- Stenosis of a.subclavia

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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)

Locations
Country Name City State
Germany Goethe Universität Frankfurt Hessen

Sponsors (2)
Lead Sponsor Collaborator
Johann Wolfgang Goethe University Hospitals Pitzer Stiftung

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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) Participants will be followed for the duration of hospital stay (5 POD) and a follow up visit 3 months after discharge Yes
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