From: Clinical review: Fresh frozen plasma in massive bleedings - more questions than answers
Most important challenges | Proposed solutions |
---|---|
Avoid survivorship bias | Exclude patients not expected to live long enough to receive plasma |
 | Precise documentation of the time of transfusions and death |
 | 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 |
 | Close cooperation between blood bank, trauma, anaesthesia and critical care |
 | Thawed AB plasma 24/7 or rapid thawing (microwave) |
 | 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 |
 | Measure clotting factor levels |
Discriminate coagulopathic from mechanical bleeding | Measure indicators of coagulopathy: |
 | • Thromboelastography |
 | • Clotting factor assays |
 | • Markers of hyperfibrinolysis |
 | • Tissue hypoperfusion (lactate, base deficit) |
 | • Progression of bleeding by computerized tomography scan (that is, progression brain |
 | contusion, retroperitoneal haematomas) |
 | • Ask the physician's opinion (that is, surgeon, anaesthetist, intensivist) |
Immediate cessation of component therapy | Evidence that bleeding has stopped |
 | 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 |