Cannulation of the Artery Axiliaris for Extracorporeal Circulation

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01615172

Enrollment

120

Registered

2012-06-08

Start date

2011-01-31

Completion date

2014-12-31

Last updated

2014-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurologic Manifestations

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.

Interventions

PROCEDUREcannulation

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)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 85 Years

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* Stenosis of a.subclavia

Design outcomes

Primary

Measure	Time frame	Description
Surrogat endpoint: Number of participants with change from baseline in Neurolocial events at 5th postoperative day (POD) and 3 month after operation	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)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026