Preservation of hearts prior to heart transplantation in children MedDRA version: 21.1 Level: PT Classification code 10019314 Term: Heart transplant System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
Trade Name: Custodiol-N
Product Name: Custodiol-N
Pharmaceutical Form: Solution for cardioplegia/organ preservation
INN or Proposed INN: Sodium
Other descriptive name: Sodium
Concentration unit: mmol/
Sponsors
Dr. Franz Köhler Chemie GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patient criteria: - Age from birth to less than18 years - Recipients awaiting their first transplant - Ability of the patients and/ or their legal guardians to understand character and individual consequences of the clinical trial - written informed consent of the patients and/ or their legal guardians (must be available before enrolment in the study) - Patient listed on the waiting list for heart transplantation Donor criteria: - deceased donors should fulfil the standard criteria for organ donation (SCD) Are the trial subjects under 18? yes Number of subjects for this age range: 15 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patient criteria: - Patients who have participated within 30 days or are still participating in any other interventional studies - history of severe organic disease other than concerning the heart - history/demonstration of HIV antibodies or AIDS - multiorgan transplantation - machine-perfused organ - the explantation team is affiliated to another clinic than transplantation team -Failing Fontan patients -Pregnancy and lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of this investigation is to compare the safety of two organ preservation solutions,Custodiol and Custodiol-N, in paediatric patients undergoing heart transplantation Primary: Safety assessment, i.e. continuous adverse event reporting up to 3 months;Secondary Objective: Main Secondary - vital parameters up to day 7 - laboratory tests including cardiac troponin and creatinine kinase (CK-MB) up to day 7 - Haemodynamics from termination of cardiopulmonary bypass until transfer to intensive care unit - Death up to 3 months - Graft survival up to 3 months - Readmission to ICU up to 3 months - Length of ICU stay up to 3 months - Catecholamine requirement up to day 7 - Milrinone support up to day 7 - Need for pacemaker therapy up to day 7 - Need for mechanical circulatory support post-Tx - Echocardiographic markers of function and rejection up to day 7 - Cardiac arrhythmias up to day 7;Primary end point(s): Safety assessment, i.e. continuous adverse event reporting up to 3 months;Timepoint(s) of evaluation of this end point: after transplantation and up to 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Vital parameters (heart rate, blood pressure, body temperature) up to day 7 - Laboratory tests including cardiac troponin and creatinine kinase (CK-MB) up to day 7 - CK-MB peak value from 4 to 168 hours after release of the aortic cross clamp (measurements 4, 8, 12, 16, 20, 24± 30 min; 32h, 40h, 48h, 56h, 64h, 72h ± 2 hours; visit 4-7 one time/interval) - CK-MB AUC value visit 1-7 - Troponin T up to 168 hours after release of the aortic cross clamp (measurements 4, 8,12, 16, 20, 24 hours ± 30 min; 32h, 40h, 48h, 56h, 64h, 72h ± 2 hours; visit 4-7 one time/interval) - Troponin AUC value visit 1-7 - Hematology and clinical chemistry pre-operative and on visit 1,3,7 post-transplantation. - Haemodynamics at termination of cardiopulmonary bypass, and after 4h, 8h and 12h after aortic cross clamp release but only until transfer to intensive care unit (SBP, DBP), HR, PAP (if available), CVR (if available) - Death up to 3 months - Graft survival up to 3 months - Readmission to ICU up to 3 months - Length of ICU stays up to 3 months - Catecholamine requirement (yes/no) up to day 7 - Antihypertensiva intake (yes/no) up to 3 months - Milrinone support (yes/no) up to day 7 -Need for pacemaker therapy (yes/no) up to day 7 -Device therapy (each yes/no) up to 3 months (including LVAD, RVAD, ECMO, BIVAD or percutaneuos LVAD) -Echocardiographic markers of function and rejection up to day 7 (Ejection fraction, enddiastolic and endsystolic ventricle volume) -Cardiac arrhythmias up to day 7 (occurrence, severity, type);Timepoint(s) of evaluation of this end point: - vital parameters and labor tests up to day 7 after transplantation - Hematology and clinical chemistry pre-operative and on visit 1,3,7 post-transplantation - Haemodynamics at termination of cardiopulmonary bypass, and after 4h, 8h and 12h after aortic cross clamp release but only until transfer to intensive care unit - Death and graft survivial up to 3 months | — |
Countries
Germany
Contacts
Public ContactDeutsches Herzzentrum Berlin
Deutsches Herzzentrum Berlin
Outcome results
None listed