Traumatic haemorrhage Injury, Occupational Diseases, Poisoning
Conditions
Interventions
Study design
A randomised controlled trial of pre-hospital whole blood versus red blood cells and plasma (non-blinded), for the treatment of major traumatic haemorrhage.
Type of participant to be stu
Sponsors
NHS Blood and Transplant
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient (of any age) who has suffered a traumatic injury 2. Attended by a participating Air Ambulance Service (AAS) clinical team 3. Requires pre-hospital blood transfusion to treat major traumatic haemorrhage
Exclusion criteria
Exclusion criteria: 1. No intravenous or intraosseous access 2. Knowledge that the patient will object to being given blood transfusion for any reasons 3. Blood already administered on-scene, prior to the arrival of the participating Air Ambulance team
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of participants with traumatic haemorrhage who have died (all-cause mortality) or received a total of 10 or more units of any blood components in the first 24 hours from randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical Outcomes: 1. Individual components of the primary outcome: Proportion of participants who: 1.1. Experienced all-cause mortality at 24 hours from randomisation 1.2. Received a total of 10 or more units of any blood components in the first 24 hours of randomisation IV 2. All-cause mortality within 6 hours and separately 30 and 90 days of randomisation IV 3. Number of organ failure free days up to 30 days after randomisation, defined as the number of days free of advanced cardiovascular, advanced respiratory and advanced renal support. Each component of organ failure-free days will also be reported separately: 3.1. Number of days free of advanced respiratory support 3.2. Number of days free of advanced cardiovascular support 3.3. Number of days free of advanced renal support 4. Days in critical care and separately in an acute care hospital (up to 90 days) 5. Units of each blood component received in the 24 hours after randomisation IV (including prehospital transfusions): whole blood (WB) and red blood cells (RBC), plasma, platelets and cryoprecipitate 6. Amount of cell salvage received at 24 hours (in ml) after randomisation IV 7. Number of participants receiving additional haemostatic agents received at 24 hours after randomisation IV: recombinant Factor VIIa, fibrinogen concentrate, prothrombin complex concentrate (PCC), tranexamic acid (TXA) 8. Presence of coagulopathy (defined as prothrombin time above the limits of a normal range) in the first sample taken on arrival at an acute care hospital 9. Acid-base disturbance measured by lactate, base excess and pH level in the first sample taken on arrival at an acute care hospital Cost-Effectiveness Analysis Outcomes: 1. Incremental cost of the whole blood intervention 2. Hospital resource use to discharge or death 3. Health, social and wider care resource use to 90 days after randomisation 4. Health-related quality of life measured by EQ-5D-5L at 90 days after randomisation Safety Outcomes: 1. Thrombosis (a | — |
Countries
England, United Kingdom
Contacts
Public ContactViona;Joanne Rundell;Lucas
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Outcome results
None listed