Major trauma haemorrhage Injury, Occupational Diseases, Poisoning
Conditions
Interventions
Adult Trauma patients admitting to recruiting Major Trauma Centres, who are eligible for the trial, will be entered into the trial using an emergency waiver of consent. Patients on arrival will be in
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. The participant is judged to be an adult (according to local practice, e.g. 16 years or older in UK) and has sustained severe traumatic injury 2. Deemed by the attending clinician to have on-going active haemorrhage 3. Requires activation of the local major haemorrhage protocol for management of severe blood loss 4. Has started or received at least one unit of any blood component
Exclusion criteria
Exclusion criteria: 1. The participant has been transferred from another hospital 2. The trauma team leader deems the patient inappropriate for the trial i.e. injuries deemed to be incompatible with life 3. More than 3 hours have elapsed from the time of injury
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality at 28 days as documented and confirmed in the patients medical notes by attending physicians. The primary cause of death will be documented and if possible categorised according to the following clinical causes: 1. Uncontrolled bleeding 2. Vascular occlusion (myocardial infarction, stroke) 3. Pulmonary embolism 4. Multi-organ failure 5. Traumatic brain injury 6. Multiple injury 7. Sepsis 8. Other (reason) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. All-cause mortality (including death from bleeding) at 6 hours, 24 hours, 6 months and 12 months from admission as record in the patients medical notes during their admission and captured by the Office for National Statistics for up to 1 year post admission 2. Death from bleeding at 6 hours and 24 hours as recorded in the patients medical notes 3. Transfusion requirements, in numbers of units, for RBC, platelets, FFP & cryoprecipitate at 24 hours from admission, including pre-hospital transfusion as recorded in the patients medical notes 4. Destination of participant at time of discharge from hospital as recorded by the research team 5. Quality of life measures: EQ5D-5L and Glasgow Outcome Score at discharge and 6 months after injury captured by patient questionnaires administrated by the Trauma Audit Research Network 6. Hospital resource use up to discharge or day 28, including blood transfusions, surgical procedures, ventilator days, hours spent in critical care and in-patient stays measured by clinical data captured by the research teams in the Case Report Forms | — |
Countries
England, Northern Ireland, United Kingdom, United States of America, Wales
Contacts
Public ContactKarim Brohi
Outcome results
None listed