The TOP-ART Study: Trauma Organ Protection - Artesunate

Phase 2

Completed

• Conditions: Multiple organ failure following traumatic haemorrhage.; Injury, Occupational Diseases, Poisoning

• Registration Number: ISRCTN15731357
• Lead Sponsor: Queen Mary University of London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-08-28
• Study Completion: 2019-09-21
• Last Update Posted: 24 May 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 105

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified