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
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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.
RAMPP trial - Randomised Controlled Trial: Pleural vent (rocket) V standard care in Primary Spontaneous Pnuemothorax
Global Anticoagulant Registry in the FIELD observing treatment and outcomes in patients with treated acute Venous Thromboembolic Events in the real world
Global Anticoagulant Registry In the FIELD – Venous Thromboembolic Events
The study with PP100-01 in combination with NAC is designed to determine safety and tolerability of PP100-01 when co-administered with NAC as compared to the 12-hr NAC treatment regime for patients that come to the hospital after an overdose of paracetamol/acetaminophen.
A Randomised Open Label Exploratory, Safety and Tolerability Study with PP100-01 in Patients Treated with the 12-hour Regimen of N-Acetylcysteine for Paracetamol/Acetaminophen Overdose