the early postoperative period after liver transplantation MedDRA version: 17.0 Level: LLT Classification code 10024716 Term: Liver transplantation System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Ilomedin
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: ILOPROST
CAS Number: 78919-13-8
Concentration unit: µg/ml microgram(s)/millilitre
Concentration typ
Sponsors
Friedrich Schiller University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Full-size liver transplantation 2. Informed consent of the patient or legal representative 3. Age = 18 years 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 370 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1.Women of child-bearing potential except women with the following criteria: - post menopausal (12 month natural amenorrhoe or 6 month amenorrhoe with serum FSH > 40 mlU/ml) - sterilization 86 weeks after bilateral ovarectomy with or without hysterectomy - using an effective method of birth control for the duration of trial: implants, injectables, combined oral contraceptives, intra-uterine device (in place for a period of at least 2 months prior to screening) and with negative serum pregnancy test - sexual abstinence - vasectomised partner 2. Pregnancy/lactation 3. Respiratory and/or circulatory instability (noradrenaline > 1 µg/kgBW/min and FiO2 > 0.6) after LTx before randomization 4. Split liver transplantation / living donor related liver transplantation 5. Retransplantation 6. Multivisceral transplantation 7. Participation on other clinical trials 30 days prior to randomization 8. Known allergic reaction against trial medication 9. Conditions in which bleeding complications may be expected from the effect of Iloprost on platelets 10. Severe coronary artery disease or unstable angina pectoris 11. Myocardial infarction within the past 6 months prior to baseline assessment after acceptance of donor organ 12. Acute or chronic heart failure (NYHA II-IV) 13. Cardiac arrhythmias relevant for the prognosis 14. Suspected pulmonary artery congestion 15. known allergy or intolerance against tacrolimus, mycophenolate mofetil, basiliximab or corticosteroids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): primary graft dysfunction (PDF) after liver transplantation characterized as presentation of one or more of the following criteria: ALAT or ASAT level > 2000 IU/ml within the first 7 postoperative days, bilirubin = 10 mg/dl on postoperative day 7; INR = 1.6 on postoperative day 7 or as occurrence of initial non-function (INF) defined as graft failure originating from the graft itself, excluding hepatic artery thrombosis (HAT), biliary complication, recurrent disease or acute rejection and resulting in retransplantation or patient death within 14 days after initial LT ;Timepoint(s) of evaluation of this end point: until day 14 after liver transplantation;Main Objective: Evaluation of Iloprost in the early postoperative period after liver transplantation;Secondary Objective: during trial duration: Occurrence of any infection up to day 28 after LT; Initial non-function defined as graft failure originating from the graft itself, excluding hepatic artery thrombosis, biliary complication, recurrent disease or acute rejection and resulting in retransplantation or patient death within 14 days after initial LT; Clotting factor substitution up to day 28 after LT; Renal replacement therapy up to day 28 and 180 after LT; Liver dialysis up to day 28 and 180 after LT; Graft survival at day 28 and 180 after LT; Patient survival at day 28 and 180 after LT; Occurrence of biliary complications at day 28 and 180 after LT; Length of ICU stay in days up to day 180 after LT; Length of hospital stay in days up to day 180 after LT; Course of ASAT/ALAT, Quick’s value/INR, Factor V and ICG-PDR until day 7 after LT; Change in SOFA-score from day 1 to day 7 after LT Follow-up assessment 270 and 360 days after LT: Graft survival;Patient survival;Occurrence of biliary complications | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): during trial duration - Occurrence of any infection up to day 28 after LT - Initial non-function (INF) defined as graft failure originating from the graft itself, excluding hepatic artery thrombosis (HAT), biliary complication, recurrent disease or acute rejection and resulting in retransplantation or patient death within 14 days after initial LT - Clotting factor substitution up to day 28 after LT - Renal replacement therapy up to day 28 and 180 after LT - Liver dialysis up to day 28 and 180 after LT - Graft survival at day 28 and 180 after LT - Patient survival at day 28 and 180 after LT - Occurrence of biliary complications at day 28 and 180 after LT - Length of ICU stay in days up to day 180 after LT - Length of hospital stay in days up to day 180 after LT - Course of ASAT/ALAT, Quick’s value/INR, Factor V and ICG-PDR until day 7 after LT - Change in SOFA-score from day 1 to day 7 after LT Follow-up assessment 270 and 360 days after LT: - Graft survival - Patient survival - Occurrence of biliary complications ;Timepoint(s) of evaluation of this end point: see above in E.5.2 | — |
Countries
Germany
Contacts
Public ContactDept. of Gen., Vis. and Vasc. Surg
Friedrich Schiller University
Outcome results
None listed