Developing a new test for liver injury after taking too much paracetamol
Not Applicable
- Conditions
- Diagnosis of liver injury in patients presenting with paracetamol overdoseInjury, Occupational Diseases, PoisoningPoisoning by nonopioid analgesics, antipyretics and antirheumatics
- Registration Number
- ISRCTN11484200
- Lead Sponsor
- Accord (United Kingdom)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 620
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
1. Deemed unfit by the Investigator or treating clinician to participate
2. Detained under the Mental Health (Care and Treatment) (Scotland) Act 2003
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 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)<br> 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<br>
- Secondary Outcome Measures
Name Time Method <br> 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)<br> 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<br>