Understanding Liver Dysfunction After Stem Cell Transplant

This study is looking at how liver problems (liver dysfunction) develop in people who have had a hematopoietic stem cell transplant (HSCT). HSCT is a treatment for many cancers and other illnesses. Researchers want to understand why some people develop liver problems after this transplant and how existing liver conditions might affect the transplant's outcome. They will observe 500 participants, aged 3 to 90, who are being considered for an HSCT. The main goal is to see if people with liver disease before their transplant are more likely to die or have severe liver problems within 91 days after the transplant. This is an observational study, meaning no specific interventions are being tested.

Study design
This is an observational study with a planned enrollment of 500 participants. It is designed to understand the natural progression of liver dysfunction after transplant.
What's involved
You would have 11 study visits over 4 years, with most visits occurring in the first year after your transplant.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes, such as death or severe liver problems, will be measured 91 days after the transplant.

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NCT05722210

Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant

Not Yet Recruiting
Not specifiedAges 3–90Observational
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
~500 participants
Updated 2026-08-28 on ClinicalTrials.gov

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Death or total bilirubin >=4 at 91 days after the transplant
Measured over 91 days after transplant
+1 more outcome measured
Hematopoietic Stem Cell Transplant
1 sites across 1 states
Maryland1
  • Theo Heller, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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Eligibility criteria

Inclusion

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

Exclusion

Pregnancy or lactation
Unable to comply with study procedures
Inability to provide written informed consent
  • Death or total bilirubin >=4 at 91 days after the transplant91 days after 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 rate91 days after 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.