Trauma Organ Protection - Artesunate

Phase 1

• Conditions: Organ Dysfunction and Failure in Traumatic Hemorrhage; Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]

• Registration Number: EUCTR2015-000301-40-GB
• 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: 2015-11-30
• Last Update Posted: 16 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 105

Inclusion Criteria

A patient will be eligible for the study if they meet the following criteria;

• Adult trauma patients
• Activation of the local massive haemorrhage protocol
• Patients with active, ongoing haemorrhage

Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

The principle exclusion critieria include:

• Patients not expected to survive >48 hours
• Patients with evidence of severe traumatic brain injury (GCS 3 at scene)
• Known pregnancy
• Suspected non-haemorrhagic cause of shock
• Massive haemorrhage protocol activation >1 hour after arrival
• IMP administration not attainable within 4 hours of injury
• Admission greater than 2 hours post injury
• Breastfeeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified