Biomarkers in Liver Failure

NCT02833064 | Active Not Recruiting

• 1 other identifier: AC16086
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Acute Liver Failure; Acute Liver Injury; Acute on Chronic Hepatic Failure

Outcome Measures

Primary Outcomes (1)

• Identification of biomarkers and radiological markers predictive of development of complications and outcomes in acute liver injury and acute liver failure.

  10 years

Secondary Outcomes (1)

• Identification of proteins involved in the pathogenesis of acute liver injury and acute liver failure

  10 years

Study Arms (5)

Acute Liver Failure

* biological sampling * MRI scanning for patients with paracetamol induced acute liver failure

Radiation: Non-contrast magnetic resonance imaging; Other: Biological sampling

Acute Liver Injury

\- biological sampling

Other: Biological sampling

Acute on Chronic Hepatic Injury

\- biological sampling

Other: Biological sampling

Stable Cirrhotics

\- biological sampling

Other: Biological sampling

Non-cirrhotic liver disease

\- biological sampling

Other: Biological sampling

Interventions

Non-contrast magnetic resonance imaging RADIATION

Acute Liver Failure

Biological sampling OTHER

Blood, urine, stool and breath sampling and analysis

Acute Liver Failure; Acute Liver Injury; Acute on Chronic Hepatic Injury; Non-cirrhotic liver disease; Stable Cirrhotics

Eligibility Criteria

• Age: 16 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. Acute liver failure 2. Acute liver injury 3. Acute on chronic hepatic failure 4. Stable cirrhotics 5. Non-cirrhotic liver disease

You may qualify if:

• 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

You may not qualify if:

• refusal of consent
• withdrawal of consent

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

MeSH Terms

Conditions

Liver Failure, Acute

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2016
• First Posted: July 14, 2016
• Study Start: November 28, 2016
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-07