Skip to main content
. 2010 Jan 28;14(1):202. doi: 10.1186/cc8205

Table 2.

Challenges and proposed solutions to future clinical trials on haemostatic resuscitation

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