Early cryoprecipitate in major trauma haemorrhage: CRYOSTAT-2

INTERVENTION: 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 incapacitated as a result of their injuries and ongoing bleeding and therefore will be unable to provide informed consent. Professional consultees (physicians who are not part of the study team) will provide approval for the patient to continue in the study until such time it is possible to speak with the patient and/or their next of kin. Participants will be randomised to one of two groups using opaque sealed randomisation envelopes to enable rapid access and timely recruitment in the emergency setting. Control group: Participants receive care using the tandard major haemorrhage protocol only. This involves administering red blood cells, fresh frozen plasma and platelets following a major haemorrhage protocol (MHP) as part of a balanced resuscitation. Intervention group: Participants receive early cryoprecipitate – 3 pools (equivalent to 15 single units cryoprecipitate or 6g fibrinogen supplementation), infused as rapidly as possible, within 90 minutes of admission in addition to the standard (local) major haemorrhage Patients will be followed up for death up until study day 28 and for up to 1 year post admission with the Office for National Statistics. Follow up for quality of life will be undertaken at 6 months post injury via the Trauma Audit Research Network. CONDITION: Specialty: Injuries and emergencies, Primary sub‐specialty: Injuries and emergencies; UKCRC code/ Disease: Injuries and Accidents/ Injuries involving multiple body regions ; Injury, Occupational Diseases, Poisoning ; Trauma PRIMARY OUTCOME: 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); 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 SECONDARY OUTCOME: 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