NCT03497104

Brief Summary

Paracetamol overdose is one of the most common medical emergencies. Annually in the UK, 100,000 people seek medical attention and 50,000 need hospital admission. Treatment is with the antidote acetylcysteine (NAC), which is effective but takes 21 hours to administer intravenously and frequently produces adverse reactions. Current tools that are used to decide who needs treatment are inadequate. this trial team have identified and validated new blood tests that accurately identify those patients at risk of liver injury by quantifying the fundamental in vivo toxicity mechanisms. This study aim to gain further samples in order to develop a new point-of-care test specifically for the detection of liver damage.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
464

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 5, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 13, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

November 15, 2023

Status Verified

September 1, 2022

Enrollment Period

4.9 years

First QC Date

April 5, 2018

Last Update Submit

November 14, 2023

Conditions

Paracetamol Overdose

Outcome Measures

Primary Outcomes (1)

  • To establish a biobank of human serum samples from patients with paracetamol overdose to develop and test the performance of our POC Test

    3 years

Interventions

Surplus blood testsOTHER

Surplus blood donation

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients presenting to Emergency Department or Acute Medical Unit with paracetamol overdose

You may qualify if:

  • Age 16 years and over.
  • Hospital attendance with paracetamol overdose alone or as part of a mixed overdose
  • Patient is able to give informed consent

You may not qualify if:

  • Patient detained under the Mental Health Act
  • Inability to provide informed consent
  • Unreliable history of overdose
  • Prisoners

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NHS Lothian

Edinburgh, United Kingdom

Location

Related Links

Study Officials

  • James Dear

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 5, 2018

First Posted

April 13, 2018

Study Start

July 1, 2018

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

November 15, 2023

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)