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

Phase 3

Active, not recruiting

• Conditions: K74.6; K72.0; T86.40; T86.41; Other and unspecified cirrhosis of liver; Acute and subacute hepatic failure

• Registration Number: DRKS00003514
• Lead Sponsor: Friedrich Schiller Universität Jena -Universitätsklinikum Jena

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-20
• Study Completion: 2014-12-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting stopped after recruiting started
• Sex: All
• Target Recruitment: 37

Inclusion Criteria

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
primary graft dysfunction (PDF) after liver transplantation characterized as<br>presentation of one or more of the following criteria: ALAT or ASAT level > 2000<br>IU/ml within the first 7 postoperative days, bilirubin = 10 mg/dl on postoperative<br>day 7; INR = 1.6 on postoperative day 7 or as occurrence of initial non-function<br>(INF) defined as graft failure originating from the graft itself, excluding hepatic<br>artery thrombosis (HAT), biliary complication, recurrent disease or acute rejection<br>and resulting in retransplantation or patient death within 14 days after initial LT