Multiple organ failure following traumatic haemorrhage. Injury, Occupational Diseases, Poisoning Multiple organ failure following traumatic haemorrhage.
Conditions
Interventions
The trial Intervention arm will be split into two stages:
The first stage will be randomised 2:1 low dose intervention (2.4mg/kg) versus placebo.
The second stage will
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult trauma patients (16 years and above). 2. Activation of the local massive haemorrhage protocol 3. Patients with active, ongoing haemorrhage 4. Agreement for participation is provided on behalf of incapacitated patients by Personal Consultee or Nominated Consultee (i.e. trauma team leader)
Exclusion criteria
Exclusion criteria: 1. Time of admission more than 2 hours after the time of injury 2. Time of drug administration not attainable within 4 hours of injury 3. Subject not expected to survive more than 48 hours 4. Evidence of severe traumatic brain injury (GCS 3 at scene) 5. Known pregnancy 6. Suspected non-haemorrhagic cause of shock 7. Massive haemorrhage protocol activation more than one hour after arrival 8. Concurrent participation in another Clinical Trial of an IMP 9. Breastfeeding females 10. Known allergy to Artesunate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sequential Organ Failure Score (SOFA) at 48 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Maximum Sequential Organ Failure Score (SOFA) over 7 days 2. Total length of hospital stay 3. Total number of days on organ support (as measured by CTCOFR score) 4. Total length of critical care stay 5. Number of ventilator free days 6. Incidence of acute lung injury (as measured by Lung Injury Score) 7. Incidence of acute kidney injury (as measured by RIFLE score) 8. Incidence of infection 9. Mortality (measured at discharge, after 28 days and after 90 days) | — |
Countries
United Kingdom
Outcome results
None listed