A multi-centre randomised controlled trial of the clinical and cost-effectiveness of pre-hospital whole blood administration versus standard care for traumatic haemorrhage
Traumatic haemorrhage
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 studied Patients (of any age) who require a blood transfusion in the pre-hospital setting, for the treatment of major traumatic haemorrhage. Setting Pre-Hospital Emergency Medicine. Randomisation Randomised boxes containing the trial intervention (either two units of whole blood or two units of red blood cells and two units of plasma) will be prepared in advance by the Transfusion Laboratory Teams. The boxes will be supplied to the participating Air Ambulance Services. If they attend to a patient who has suffered major trauma and requires blood transfusion, the team will open the trial intervention box and administer the contents to the patient, in accordance with standard local blood transfusion protocols. The time that the box was opened will be recorded and referred to as the randomisation time for the purposes of follow-up data collection. Informed consent will not be obtained prior to the initiation of treatment, due to the life-threatening nature of the patient’s condition. Patients will be enrolled under an emergency waiver of consent, and informed consent will be sought (either directly from the participant, if they have capacity, or via a representative) as soon as practically possible. Treatment The intervention arm will be up to two units of whole blood (www.transfusionguidelines.org/red-book/annex-3/a3-6-whole-blood-leucocyte-depleted-for-clinical-studies). The control arm will be up to two units of red blood cells and up to 2 units of plasma (this is the current standard of care for the participating Air Ambulance Services). The plasma used in the control arm will either be fresh-frozen plasma (FFP) or LyoPlas (freeze-dried plasma). LyoPlas is classified as an IMP as it involves a manufacturing process. All other products used in this trial are blood compon
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
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