A prospective, multi-center, randomized, double blinded, placebo-controlled study for the evaluation of Iloprost in the early postoperative period after liver transplantation

A prospective, multi-center, randomized, double blinded, placebo-controlled study for the evaluation of Iloprost in the early postoperative period after liver transplantation - PRAISE-Study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

DRKS

Registry ID

DRKS00003514

Enrollment

430

Registered

2012-03-20

Start date

2012-04-30

Completion date

Unknown

Last updated

2025-10-06

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

Conditions

K74.6 K72.0 T86.40 T86.41

Interventions

Group 1: Intervention: Ilomedin (Iloprost), 1ng/kg BW/min intra-venous (with infusion pump - type Perfusor) continously seven days Group 2: Control group: Placebo, 1ng/kg BW/min intra-venous (with inf

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: - Full-size liver transplantation - Informed consent of the patient or legal representative - Age = 18 years

Exclusion criteria

Exclusion criteria: - Women of child-bearing potential except women with the following criteria: o post menopausal (12 months natural amenorrhea or 6 month amenorrhea with serum FSH > 40 mlU/ml) o sterilization 86 weeks after bilateral ovarectomy with or without hysterectomy o 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 o sexual abstinence o vasectomised partner - Pregnancy/lactation - Respiratory and/or circulatory instability (noradrenaline > 1 µg/kgBW/min and FiO2 > 0.6) after LT before randomization - Split liver transplantation/living donor related liver transplantation - Retransplantation - Receiving a multi-organ transplantation - Participation on other clinical trials 30 days prior to randomization - Known allergic reaction against trial medication - Conditions in which bleeding complications may be expected from the effect of Iloprost on platelets - Severe coronary artery disease or unstable angina pectoris - Myocardial infarction within the past 6 months prior to baseline assessment after acceptance of donor organ - Acute or chronic heart failure (NYHA II-IV) - Cardiac arrhythmias relevant for the prognosis - Suspected pulmonary artery congestion - Known allergy or intolerance against tacrolimus, mycophenolate mofetil, basiliximab or corticosteroids

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

—

Secondary

Measure	Time frame
- 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 (maximum) - Length of hospital stay in days up to day 180 after LT (maximum) - 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; Assessment of safety: occurrence of bleeding complications, circulatory instability (assessment of catecholamines administration, mean arterial pressure, heart rate), pulmonary disturbance (blood-gas analysis, FiO2,PEEP, arterial oxygen saturation, pO2, pCO2), incidence of AEs and SAEs	—

Measure

Time frame

- 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 (maximum) - Length of hospital stay in days up to day 180 after LT (maximum) - 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; Assessment of safety: occurrence of bleeding complications, circulatory instability (assessment of catecholamines administration, mean arterial pressure, heart rate), pulmonary disturbance (blood-gas analysis, FiO2,PEEP, arterial oxygen saturation, pO2, pCO2), incidence of AEs and SAEs

—

Countries

Germany

Contacts

Public ContactErik Bärthel

Universitätsklinikum JenaKlinik für Allgemein-, Viszeral- und Gefäßchirurgie

avg@med.uni-jena.de+49 (0) 3641 932 26 88

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 24, 2026