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Phase III Study Comparing Two Methods of Cardioplegia in Coronary Artery Bypass Surgery

NCT01444235 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 102

Last updated 2013-05-17

No results posted yet for this study

Summary

Comparison of the cardioprotective effects and safety of two cardioplegic solutions (solutions used during a cardiac arrest in the heart surgery) in patients undergoing cardiopulmonary bypass for coronary artery bypass surgery.

Conditions

  • Coronary Artery Disease (CAD)

Interventions

DRUG

Custodiol-N

Route of administration: by infusion Dosage: will be infused antegrade into the root of the aorta until 1500-2000 mL of solution have been infused Duration: infusion technique will be continued for seven minutes

DRUG

Custodiol

Route of administration: by infusion duration: infusion technique will be continued for seven minutes dosage: until 1500-2000 mL of solution have been infused

Sponsors & Collaborators

  • Dr. F. Köhler Chemie GmbH

    lead INDUSTRY

Principal Investigators

  • Gabor Szabo, Prof. Dr. · Department of Cardiac Surgery of University of Heidelberg

  • Nikolaus Pizanis, Dr. · Klinik für Thorax- und Kardiovaskuläre Chirurgie, Universitätsklinikum Essen

  • Florian Wagner, Dr. · Klinik für Herz- und Gefäßchirurgie, Universitäts-Krankenhaus Eppendorf

  • Thorsten Doenst, Prof. Dr. · Klinik für Herz- und Thoraxchirurgie, Universitätsklinikum Jena

  • Martin Misfeld, Dr. · Herzzentrum Leipzig GmbH, Klinik für Herzchirurgie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2012-05-31
Completion
2012-07-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01444235 on ClinicalTrials.gov