Skip to main content

Table 2 Challenges and proposed solutions to future clinical trials on haemostatic resuscitation

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