Evaluation of iloprost in the postoperative period after liver transplantatio

Not Applicable

Completed

• Conditions: iver transplantation; Injury, Occupational Diseases, Poisoning; Liver transplant failure and rejection

• Registration Number: ISRCTN12622749
• Lead Sponsor: Friedrich-Schiller-University Jena (Germany)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-02
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 356

Inclusion Criteria

Current inclusion criteria as of 07/03/2013:
1. Full-size liver transplantation
2. Informed consent of the patient or legal representative
3. Aged 18 years or over

Previous inclusion criteria:
1. Full-size liver transplantation
2. Informed consent of the patient or legal representative
3. Age over 18 years

Exclusion Criteria

1. Women of child-bearing potential except women with the following criteria:
1.1. Post menopausal (12 months natural amenorrhea or 6 month amenorrhea with serum FSH > 40 mlU/ml)
1.2. Sterilization 86 weeks after bilateral ovarectomy with or without hysterectomy
1.3. Using an effective method of birth control for the duration of trial:
1.3.1 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
1.4. Sexual abstinence
2. Pregnancy/lactation
3. Respiratory and/or circulatory instability (noradrenaline > 1 pg/kgBWmin and FiOz > 0.6) after liver transplantation (LT) before randomization
4. Split liver transplantation/living donor related liver transplantation
5. Retransplantation
6. Receiving a multi-organ 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 lloprost 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 ll-lV)
13. Cardiac arrhythmias relevant for the prognosis
14. Suspected pulmonary artery congestion
15. Known allergy or intolerance against tacrolimus, mycophenolate mofetil, basiliximab or corticosteroids

Study & Design

• Study Type: Interventional
• Study Design: Not specified