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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-001112-29-DE

Enrollment

Unknown

Registered

2015-01-16

Start date

2015-07-27

Completion date

Unknown

Last updated

2020-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients that has to undergo (is suitable for) a heart transplantation

Interventions

Trade Name: Custodiol® Product Name: Custodiol® Pharmaceutical Form: Solution for organ preservation Other descriptive name: SODIUM CHLORIDE Concentration unit: mmol/l millimole(s)/litre Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

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) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of this investigation is to demonstrate non-inferiority in outcome of Custodiol-N against Custodiol in heart transplantation. CK-MB peak value 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 Objective: 1. Catecholamine requirement, defined as “yes” or “no”. 2. Patient survival at 7 days and 1, 3 and 12 months 3. Complications: occurrence, severity, type, and duration 4. Length of ICU stay 5. Requirement of IABP 6. Ejection fraction, cardiac index at day 1 and 7 (if available) 7. Enddiastolic and endsystolic ventricle volume (EDV and ESV) at day 1 and 7 (if available) 8. Incidence of primary poor function (need for assist device or retransplantation) ;Primary end point(s): CK-MB peak value;Timepoint(s) of evaluation of this end point: from 4 to 168 hours after release of the aortic cross clamp.It will be taken as the maximum over the measurements made at 4, 8, 12, 16, 20, 24 hours (± 30 min), 32, 40, 48 hours ± 2 hours, day 4-7 once daily.	—

Measure

Time frame

Main Objective: The objective of this investigation is to demonstrate non-inferiority in outcome of Custodiol-N against Custodiol in heart transplantation. CK-MB peak value 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 Objective: 1. Catecholamine requirement, defined as “yes” or “no”. 2. Patient survival at 7 days and 1, 3 and 12 months 3. Complications: occurrence, severity, type, and duration 4. Length of ICU stay 5. Requirement of IABP 6. Ejection fraction, cardiac index at day 1 and 7 (if available) 7. Enddiastolic and endsystolic ventricle volume (EDV and ESV) at day 1 and 7 (if available) 8. Incidence of primary poor function (need for assist device or retransplantation) ;Primary end point(s): CK-MB peak value;Timepoint(s) of evaluation of this end point: from 4 to 168 hours after release of the aortic cross clamp.It will be taken as the maximum over the measurements made at 4, 8, 12, 16, 20, 24 hours (± 30 min), 32, 40, 48 hours ± 2 hours, day 4-7 once daily.

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Secondary

Measure	Time frame
Secondary end point(s): 1. Catecholamine requirement, defined as “yes” or “no”. 2. Patient survival at 7 days and 1, 3 and 12 months 3. Complications: occurrence, severity, type, and duration 4. Length of ICU stay 5. Requirement of IABP 6. Ejection fraction, cardiac index (if available) 7. Enddiastolic and endsystolic ventricle volume (EDV and ESV) (if available) 8. Incidence of primary poor function (need for assist device or retransplantation) ;Timepoint(s) of evaluation of this end point: see above (Point E.5.2)	—

Measure

Time frame

Secondary end point(s): 1. Catecholamine requirement, defined as “yes” or “no”. 2. Patient survival at 7 days and 1, 3 and 12 months 3. Complications: occurrence, severity, type, and duration 4. Length of ICU stay 5. Requirement of IABP 6. Ejection fraction, cardiac index (if available) 7. Enddiastolic and endsystolic ventricle volume (EDV and ESV) (if available) 8. Incidence of primary poor function (need for assist device or retransplantation) ;Timepoint(s) of evaluation of this end point: see above (Point E.5.2)

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Countries

Austria, Germany

Contacts

Public ContactDr. Roman Petrov

Dr. Franz Köhler Chemie GmbH

r.petrov@koehler-chemie.de+49625110830

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026