Study of Organ Perfusion With Custodiol-N Solution Compared With Custodiol Solution in Heart Transplantation
NCT02869022 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 105
Last updated 2020-01-18
Summary
The objective of this investigation is to demonstrate non-inferiority in outcome of Custodiol-N against Custodiol in heart transplantation.
Conditions
Interventions
- DRUG
-
Custodiol-N
comparison of two Solutions, Custodiol-N versus Custodiol, for organ Perfusion in heart transplantation
- DRUG
-
Custodiol
comparison of two Solutions, Custodiol-N versus Custodiol, for organ Perfusion in heart transplantation
- PROCEDURE
-
organ perfusion for heart transplantation
Sponsors & Collaborators
-
Dr. F. Köhler Chemie GmbH
lead INDUSTRY
Principal Investigators
-
Gabor Szabo, Prof. Dr. · Abt. Herzchirugie, Universitätsklinikum Heidelberg
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-07-31
- Primary Completion
- 2019-09-02
- Completion
- 2019-09-02
Countries
- Austria
- Germany
Study Locations
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