Toggle menu

The POP Trial

Start date:
June 2017
End date:
December 2018
Co-ordinated by:
EMERGE, RIE
Main trial site:
RIE

Paracetamol can be harmful to the liver when an excessive dose has been taken. To help prevent liver damage, an antidote known as acetylcysteine is given. However a few patients can develop liver damage even if they get acetylcysteine. This study will give a new drug (calmangafodipir) in combination with acetylcysteine to see if using these two drugs together is safe and if it is better at preventing damage to the liver than using acetylcysteine only. If you take part you will receive either acetylcysteine and calmangafodipir or acetylcysteine alone.

As a secondary objective possible efficacy will be explored by using experimental biomarkers in serum/plasma, such as CK18 and microRNA MiR122, GLDH, mitochondrial DNA and others that might give efficacy signals for PP100-01. The diagnosis of paracetamol/acetaminophen overdose will be made by ALT and paracetamol/acetaminophen measurements.
This study includes several comparisons;
• Safety and tolerability of PP100-01 + NAC vs NAC alone
• Assess hepatotoxicity in patients after POD as assessed using ALT, INR and experimental biomarkers of liver damage

 

GDPR Privacy Statement

If you have participated in the POP study and would like to read how the study complies with GDPR, please click on this link: GDPR Participant Information

Chief Investigator

Dr James Dear

Consultant in Acute Medicine & Toxicology

Research Team

Bernadette Gallagher

Senior Research Nurse

Kat Oatey

ECTU Trial Manager

Julia Grahamslaw

Lead Research Nurse

More EMERGE Trials

Intervention
1. Ambulatory Device, Rocket Pleural vent insertion
2. Standard Treatment, Aspiration +/- chest drain
Primary Outcome Measures
To assess whether use of an ambulatory device (Rocket Pleural Vent) and treatment strategy reduces hospital stay. Total length of stay in hospital up to 30 days post randomisation. Up to 30 days post randomisation.

Read more

RAMPP trial

RAMPP trial - Randomised Controlled Trial: Pleural vent (rocket) V standard care in Primary Spontaneous Pnuemothorax

The Emergency Medicine Annotated Bioresource Consortium (EM-ABC): A pilot and feasability programme

Read more

EMERGE Biobank

Developing a bioresource for all emergency presentations

Developing a molecular tool to stratify the acute joint presentation: facilitating early diagnosis of septic arthritis (Septic Arthritis Biomarker Emergency Rule-out - SABER)

Read more

SABER

Developing a molecular tool to stratify the acute joint presentation: facilitating early diagnosis of septic arthritis (Septic Arthritis Biomarker Emergency Rule-out - SABER)