The PRAISE study: a prospective, multi-center, randomized, double blinded, placebo-controlled study for the evaluation of iloprost in the early postoperative period after liver transplantation (ISRCTN12622749)
| Autor: | Erik Bärthel, Utz Settmacher, Heike Hoyer, Maria Breternitz, Karin Jandt, Falk Rauchfuß |
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| Rok vydání: | 2012 |
| Předmět: |
Adult
Male medicine.medical_specialty Time Factors Adolescent medicine.medical_treatment lcsh:Surgery Placebo-controlled study Primary Graft Dysfunction Ischemia-reperfusion injury Prostacyclin Liver transplantation Initial non-function Young Adult Study Protocol Double-Blind Method medicine Humans Iloprost Postoperative Period Prospective Studies Prospective cohort study Aged business.industry Primary graft dysfunction lcsh:RD1-811 General Medicine Perioperative Middle Aged Epoprostenol Surgery surgical procedures operative Treatment Outcome Anesthesia Prostaglandins Platelet aggregation inhibitor lipids (amino acids peptides and proteins) Administration Intravenous Female business Platelet Aggregation Inhibitors medicine.drug |
| Zdroj: | BMC Surgery BMC Surgery, Vol 13, Iss 1, p 1 (2013) |
| ISSN: | 1471-2482 0000-3514 |
| Popis: | Background Liver graft dysfunction can deteriorate to complete organ failure and increases perioperative morbidity and mortality after liver transplantation. Therapeutic strategies reducing the rate of graft dysfunction are of current clinical relevance. One approach is the systemic application of prostaglandins, which were demonstrated to be beneficial in reducing ischemia-reperfusion injury. Preliminary data indicate a positive effect of prostacyclin analogue iloprost on allograft viability after liver transplantation. The objective of the study is to evaluate the impact of iloprost in a multi-center trial. Methods/Design A prospective, double-blinded, randomized, placebo-controlled multicenter study in a total of 365 liver transplant recipients was designed to assess the effect of intravenous iloprost after liver transplantation. Primary endpoint will be the primary graft dysfunction characterized as presentation of one or more of the following criteria: ALAT or ASAT level > 2000 IU/ml within the first 7 postoperative days, bilirubine ≥ 10 mg/dl on postoperative day 7; INR ≥ 1.6 on postoperative day 7 or initial non-function. Secondary endpoints are parameters of post-transplant morbidity, like rates of infections, biliary complications, need of clotting factors or renal replacement therapy and the graft and patient survival. Discussion A well-established treatment concept to avoid graft dysfunction after liver transplantation does not exist at the moment. If the data of this research project confirm prior findings, iloprost would improve the general outcome after liver transplantation. Trial Registration German Clinical Trials Register: DRKS00003514. Current Controlled Trials Register: ISRCTN12622749. |
| Databáze: | OpenAIRE |
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