Biomarkers in Liver Failure (NCT02833064) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Biomarkers in Liver Failure
200 participantsStarted 2016-11-28
Plain-language summary
Acute liver injury (ALI) and acute liver failure (ALF) are rare clinical conditions, the latter often associated with a poor outcome. To improve outcomes for these patients, clinicians need to develop a clearer understanding of the pathophysiology of this condition. Biomarkers and novel imaging techniques are vital to investigating and understanding the pathophysiology of ALI. Patients with ALI or ALF aged over 16 and due to any cause will be eligible to take part in the study. The study will involve collection of biological samples (blood, urine, stool and breath) from included patients once daily for up to 7 days. For patients undergoing liver transplantation, a small sample of explanted (removed) liver tissue will be obtained. A small subgroup of patients with paracetamol induced acute liver failure will be eligible to be included in a pilot MRI (magnetic resonance imaging) study, which will involve two MRI scans during the first 7 days of their admission. All patients will be recruited from the Royal Infirmary of Edinburgh.
Who can participate
Age range
16 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* acute liver injury (newly deranged liver function tests (LFTs) and coagulopathy with International Normalized Ratio (INR) \>1.5 in absence of chronic liver disease)
* acute liver failure ( as above, plus hepatic encephalopathy)
* acute on chronic liver failure (worsening of LFTS and development of at least 1 organ failure in patient with cirrhosis)
* stable cirrhosis
* non-cirrhotic liver disease
Exclusion Criteria:
* refusal of consent
* withdrawal of consent
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is focused on identifying biomarkers and imaging markers rather than testing a new treatment, can you help me understand what participating would actually involve — like blood draws, scans, or other tests — and whether any of that could affect my current care?
2This trial is 'active not recruiting,' which means they're no longer enrolling new patients — does that mean I can't join, and if so, are there similar biomarker or observational studies I could be considered for instead?
3Because this is an observational study measuring predictors of complications rather than offering a therapy, what would I or my family actually gain from participating compared to just receiving standard treatment for acute liver failure or injury?
4The study covers three related but different conditions — acute liver injury, acute liver failure, and acute-on-chronic liver failure — which of these applies to my situation, and does that affect whether this kind of research would even be relevant to my case?
5If the biomarkers being studied here can predict serious complications, would the results from my participation be shared with my care team in a way that could actually influence decisions about my treatment?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Identification of biomarkers and radiological markers predictive of development of complications and outcomes in acute liver injury and acute liver failure.