Avoid survivorship bias |
Exclude patients not expected to live long enough to receive plasma |
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Precise documentation of the time of transfusions and death |
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Perform analysis of transfusion as a time-dependent variable |
Avoid contamination of the control arm and avoid delay in initiating 1:1 transfusions in the intervention arm |
Transfusion guidelines for both arms clear and easy to follow |
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Close cooperation between blood bank, trauma, anaesthesia and critical care |
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Thawed AB plasma 24/7 or rapid thawing (microwave) |
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Minimize time for results of laboratory tests - consider point-of-care testing |
Multiple interventions concomitantly tested |
Standardize all aspects of resuscitation (that is, amount and type of intravenous fluid; procoagulant drugs) in control and intervention groups |
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Measure clotting factor levels |
Discriminate coagulopathic from mechanical bleeding |
Measure indicators of coagulopathy: |
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• Thromboelastography |
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• Clotting factor assays |
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• Markers of hyperfibrinolysis |
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• Tissue hypoperfusion (lactate, base deficit) |
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• Progression of bleeding by computerized tomography scan (that is, progression brain |
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contusion, retroperitoneal haematomas) |
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• Ask the physician's opinion (that is, surgeon, anaesthetist, intensivist) |
Immediate cessation of component therapy |
Evidence that bleeding has stopped |
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Consider ending by 6 hours |
Outcome |
Consider restoration of haemostasis competence |
Need for large samples |
Consider a feasibility trial prior to a large multicentre trial to identify major challenges |
Consent |
Need for delayed consent |