Trauma Organ Protection - Artesunate (TOP-ART)
Research type
Research Study
Full title
A randomised, blinded, placebo-controlled Phase 2a study to evaluate the safety and efficacy of Artesunate treatment in severely injured trauma patients with traumatic haemorrhage.
IRAS ID
169165
Contact name
Karim Brohi
Contact email
Sponsor organisation
Queen Mary University of London
Eudract number
2015-000301-40
Duration of Study in the UK
2 years, 3 months, 0 days
Research summary
Trauma is the most frequent cause of death in people under age of 40. Despite resuscitation in the emergency room, severe blood loss can lead to the dysfunction of vital organs (kidney, lung, heart, liver, brain), which ultimately may cause the death of a trauma patient. There is no specific therapy to protect organs against organ failure after traumatic hemorrhage. We have discovered that a commonly used and safe anti-malarial drug (Artesunate), which is recommended by the World Health Organisation (WHO) as the safest drug of choice for the treatment of (Falciparum) malaria, reduces the organ injury and dysfunction caused by severe blood loss and subsequent resuscitation in animals. We now wish to carry out a Phase 2a dose-finding study aimed at testing the safety and potential efficacy of Artesunate in patients with trauma and severe blood loss.
REC name
London - City & East Research Ethics Committee
REC reference
16/LO/0003
Date of REC Opinion
11 Mar 2016
REC opinion
Further Information Favourable Opinion