DRKS00003514Active, not recruitingPhase 3
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
Friedrich Schiller Universität Jena -Universitätsklinikum Jena0 sites37 target enrollmentStarted: March 20, 2012Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 3
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 37
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to one (—)
- Sex
- All
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
Investigators
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