Trials / Completed
CompletedNCT02869022
Study of Organ Perfusion With Custodiol-N Solution Compared With Custodiol Solution in Heart Transplantation
A Prospective, Randomized, Single Blind, Multicenter Phase III Study of Organ Perfusion With Custodiol-N Solution Compared With Custodiol Solution in Heart Transplantation
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 105 (actual)
- Sponsor
- Dr. F. Köhler Chemie GmbH · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this investigation is to demonstrate non-inferiority in outcome of Custodiol-N against Custodiol in heart transplantation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2016-07-01
- Primary completion
- 2019-09-02
- Completion
- 2019-09-02
- First posted
- 2016-08-16
- Last updated
- 2020-01-18
Locations
9 sites across 2 countries: Austria, Germany
Source: ClinicalTrials.gov record NCT02869022. Inclusion in this directory is not an endorsement.