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Developing a new test for liver injury after taking too much paracetamol

Point-of-care assessment of drug-induced liver injury (POC-DILI)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN11484200
Enrollment
620
Registered
2023-09-15
Start date
2023-05-01
Completion date
Unknown
Last updated
2023-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diagnosis of liver injury in patients presenting with paracetamol overdose Injury, Occupational Diseases, Poisoning Poisoning by nonopioid analgesics, antipyretics and antirheumatics

Interventions

Once consented: 1. Data will be collected on each patient including age, sex, gender, ethnicity, time of overdose, amount ingested, pattern of overdose, co-ingested medicines, blood re

Sponsors

Accord (United Kingdom)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Presentation at hospital within 5 days after suspected or confirmed paracetamol overdose (all patterns of overdose are eligible – including single and staggered overdoses whether accidental or deliberate) 2. Aged 16 years or older 3. Capacity to provide informed consent 4. Deemed suitable for study procedures by attending/treating clinician

Exclusion criteria

Exclusion criteria: 1. Deemed unfit by the Investigator or treating clinician to participate 2. Detained under the Mental Health (Care and Treatment) (Scotland) Act 2003

Design outcomes

Primary

MeasureTime frame
1. ALT measured as part of routine clinical care and recorded on the patient’s electronic medical record (daily blood results will be recorded up until day 30) 2. K18 in finger prick capillary blood measured using the Point of Care DILI Diagnostic (lateral flow assay combined with handheld Raman Spectrometer) at baseline, +2 hours then daily for up to 5 days whilst the participant is in hospital

Secondary

MeasureTime frame
1. ALT, INR and bilirubin measured as part of routine clinical care and recorded on the patient’s electronic medical record (daily blood results will be recorded up until day 30) 2. K18 from surplus blood serum measured by ELISA using the M65 Classic ELISA on days 1 and 2 if the participant is admitted and is in hospital on those days

Countries

Scotland, United Kingdom

Contacts

Public ContactJoanne Mair
tht-clinical@ed.ac.uk+44 (0)1312429180

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026