NCT01615172

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 8, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

August 6, 2014

Status Verified

August 1, 2014

Enrollment Period

3.9 years

First QC Date

June 4, 2012

Last Update Submit

August 5, 2014

Conditions

Neurologic Manifestations

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Aortic cannulation

ACTIVE COMPARATOR

routine placement of aortic cannula

Procedure: cannulation

axilaris cannulation

ACTIVE COMPARATOR

new type of cannulation

Procedure: cannulation

Interventions

cannulationPROCEDURE

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)

Also known as: MAQUET 20, 22 and 24 Fr
Aortic cannulationaxilaris cannulation

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Stenosis of a.subclavia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Goethe Universität

Frankfurt am Main, Hesse, 60590, Germany

RECRUITING

MeSH Terms

Conditions

Neurologic Manifestations

Interventions

Catheterization

Condition Hierarchy (Ancestors)

Nervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Study Officials

  • Andreas Zierer, PD.Dr

    Goethe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cardia vascular research

Study Record Dates

First Submitted

June 4, 2012

First Posted

June 8, 2012

Study Start

January 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

August 6, 2014

Record last verified: 2014-08

Locations

DE(1)