Background:
Hematopoietic stem cell transplant (HSCT) is a common treatment for many cancers and other illnesses. But many people who have HSCT go on to develop liver dysfunction. Researchers want to know more about how and why this happens. In this natural history study, they will try to learn what factors lead to liver dysfunction; how underlying liver disease may affect the results of HSCT; and how HSCT may contribute to liver dysfunction.
Objective:
To understand the links between HSCT and liver dysfunction.
Eligibility:
Adults aged 18 years or older and children 3 to 17 years who are being evaluated for HSCT.
Design:
This study involves 11 visits in 4 years. Most visits will be in the first year.
Before and after their HSCT, participants will undergo these tests:
Physical exam, including blood tests and a test of heart function. Participants will provide stool samples.
Liver biopsies. Samples of liver tissue will be removed. This may be done either by inserting a needle through the right side of the chest, or with a thin tube threaded to the liver from a vein in the neck. Adult participants will undergo this procedure 2 times: once before the HSCT and once about a year later.
Imaging scans. Participants will lie on a bed that moves into either a cylinder or a donut-shaped machine.
Ultrasound. Participants will lie still. A probe that uses sound waves will be slid over their skin to get pictures of the liver.
Fibroscan exam. This is like an ultrasound that uses a special probe to measure the toughness of the liver.
...
Male and female adults >=18 years of age and children 3-17 years of age
Undergoing evaluation for hematopoietic stem cell transplant at the NIH Clinical Center
Pregnancy or lactation
Unable to comply with study procedures
Inability to provide written informed consent
male and female subjects: adults 18 years of age and older, children 3-17 years of age undergoing hematopoietic stem cell transplant at the National Institutes of Health.
Cohort
Prospective
Not listed
Death or total bilirubin >=4 at 91 days after the transplant
To determine whether, at 91 days after transplant, patients with liver disease at transplant are more likely to have died or have a total bilirubin \>=4 than those without liver disease at transplant.
Mortality rate
To determine whether, at 91 days after transplant, patients with liver disease at transplant are more likely to have died or have a total bilirubin \>=4 than those without liver disease at transplant.
Rate of infection (type: bacterial, viral, fungal; location: central line, organ infection, sepsis, etc.)
Development of portal hypertension and sequelae (i.e., ascites, variceal bleed, thrombocytopenia, elevated portal pressure)
Morbitity/cause of death
Development of liver failure
i.e., coagulopathy with an International Normalized Ratio (INR) 1.5, and any degree of mental alteration (encephalopathy) in a subject without preexisting cirrhosis and with an illness of \<26 weeks duration, including patients with Wilson s disease, vertically acquired HBV, or autoimmune hepatitis per AASLD guidelines 2011.
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This trial is not recruiting at the moment. You can still explore other options:
