A Prospective, randomized, single blind, multicenter Phase III study of organ perfusion with Custodiol-N solution compared with Custodiol solution in Heart transplantatio

Phase 1

• Conditions: Patients that has to undergo (is suitable for) a heart transplantation; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2012-001112-29-DE
• Lead Sponsor: Dr. Franz Köhler Chemie GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-01-16
• Last Update Posted: 6 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Donor criteria:
- deceased donors should fulfil the criteria for organ donation (SCD)

Patient criteria
- recipients awaiting their first transplant
- recipients = 18 and - recipient’s signed informed consent
- waiting list

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 105
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Donor criteria:
- not applicable

Patient criteria
- recipients participating in another interventional study
- pregnant or lactating patients
- history/demonstration of HIV antibodies or AIDS
- multiorgan transplantation
- transMedics pump
- the explantation team is affiliated another clinic than transplantation team

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified