A Prospective, Randomized, Single Blind, Multicenter Phase III Study of Organ Perfusion With Custodiol-N Solution Compared With Custodiol Solution in Heart Transplantation
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 105
- Locations
- 9
- Primary Endpoint
- Creatine kinase Myocard type "CK-MB" peak value
Study Overview
Brief Summary
The objective of this investigation is to demonstrate non-inferiority in outcome of Custodiol-N against Custodiol in heart transplantation.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Donor criteria:
- •deceased donors should fulfil the criteria for organ donation (SCD) Patient criteria
- •recipients awaiting their first transplant
- •recipients ≥ 18 and >/= 65 years
- •recipient's signed informed consent
- •waiting list
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
Arms & Interventions
Custodiol
comparison of two perfusion solutions, Custodiol-N versus Custodiol, in heart transplantation
Intervention: organ perfusion for heart transplantation (Procedure)
Custodiol-N
comparison of two perfusion solutions, Custodiol-N versus Custodiol, in heart transplantation
Intervention: Custodiol-N (Drug)
Custodiol-N
comparison of two perfusion solutions, Custodiol-N versus Custodiol, in heart transplantation
Intervention: organ perfusion for heart transplantation (Procedure)
Custodiol
comparison of two perfusion solutions, Custodiol-N versus Custodiol, in heart transplantation
Intervention: Custodiol (Drug)
Outcomes
Primary Outcomes
Creatine kinase Myocard type "CK-MB" peak value
Time Frame: from 4 to 168 hours after release of the aortic cross clamp
day 1: measurements 4, 8, 12, 16, 20, 24 hours ± 30 min; day 2-3: measurements 8, 16 and 24 hours ± 2 hours; day 4-7 one time/day
Secondary Outcomes
- Catecholamine requirement(from entry to the trial up to day 7)
- Patient survival(at 7 days and 1, 3 and 12 months)
- Complications(from the time of the transplantation up to day 7)