Defibrotide for the Treatment of Severe Hepatic Veno-Occlusive Disease in Hematopoetic Stem Cell Transplant Patients
Severe Hepatic Veno-Occlusive Disease
About this trial
This is an interventional treatment trial for Severe Hepatic Veno-Occlusive Disease focused on measuring Defibrotide, Severe veno occlusive disease, Multi organ failure, Stem cell transplant, Liver, Regimen related toxicity, Day 100 survival
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of VOD, defined by jaundice (bilirubin >/= 2 mg/dL) and at least 2 of the following clinical findings, by Day+21 post stem cell transplant: ascites; weight gain >/= 5% above baseline weight; hepatomegaly. Severe VOD, defined as VOD with multi-organ failure, i.e., presence of one or both of the following, by Day+28 post stem cell transplant: renal or pulmonary dysfunction. Provide voluntary written informed consent. Exclusion Criteria: Pre-existing (prior to SCT) cirrhosis An alternative diagnosis for weight gain, ascites and jaundice Graft-versus-host disease (GVHD) grade B or higher involving liver or gut or grade C or higher involving skin Prior solid organ transplant Dependent on dialysis prior to and/or at the time of SCT Dependent on oxygen supplementation prior to SCT Significant acute bleeding or hemodynamic instability Requirement for the use of any medications that increase risk of hemorrhage will be excluded from the treatment group
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Defibrotide
Historical Control
Defibrotide treatment
Historical control group