3.4 Effect of blood components on outcomes

3.4.1 Fresh frozen plasma

Evidence Statements for Fresh frozen plasma
Evidence Statements – fresh frozen plasma
ES4.1	In patients with acute pancreatitis, the effect of FFP on mortality is uncertain.	X		NA	X	X
ES4.2	In patients with acute pancreatitis, the effect of FFP on bleeding events is uncertain.	X		NA	X	X
ES4.3	In patients with liver disease, the effect of FFP on mortality is uncertain.	X	NA	NA
ES4.4	In patients with liver disease, the effect of FFP on bleeding events is uncertain.	X	NA	NA	X

ES, evidence statement; FFP, fresh frozen plasma

=C; X=D; NA,not applicable (see Table 2.1)

Practice Points – fresh frozen plasma
PP16	The routine use of FFP in medical patients with coagulopathy (including those with liver impairment) is not supported. Tests for coagulation correlate poorly with bleeding risk in liver impairment. The underlying causes of coagulopathy should be assessed. Where FFP transfusion is considered necessary, the risks and benefits should be considered for each patient, and expert guidance sought.
PP17	For guidance on the use of FFP in specific patient groups, refer to: Patient Blood Management Guidelines: Module 1 – Critical Bleeding/Massive Transfusion (2011)⁴ Patient Blood Management Guidelines: Module 2 – Perioperative (2012)⁶ Warfarin Reversal: Consensus Guidelines, on behalf of the Australasian Society of Thrombosis and Haemostasis (2004)⁷ AHCDO guidelines for patients with specific factor deficiencies (www.ahcdo.org.au) TTP: Guidelines for the Use of Fresh-Frozen Plasma, Cryoprecipitate and Cryosupernatant (2004).⁸

AHCDO, Australian Haemophilia Centre Directors’ Organisation; FFP, fresh frozen plasma; PP, practice point; TTP, thrombotic thrombocytopenic purpura

FFP contains all the coagulation factors and proteins present in normal plasma. FFP is transfused in a range of clinical settings, including critical bleeding/massive transfusion, perioperative, warfarin reversal, liver disease, coagulation factor deficiencies and thrombotic thrombocytopenic purpura (TTP). The literature search identified Level II evidence relating to the use of FFP in two medical populations:

acute pancreatitis, where FFP has been proposed as a specific therapy to replenish important circulating proteins, particularly the naturally occurring anti-protease system
liver disease, where FFP is mainly used to replace coagulation factor deficiencies.

The search identified two RCTs (Level II) that compared FFP treatment with no FFP in acute pancreatitis.^128,129 Neither study found significant differences between the study arms in terms of mortality or gastrointestinal haemorrhage; however, both studies were underpowered to measure the effect of treatment on these outcomes. The search did not find any RCTs reporting the incidence of transfusion-related serious adverse events in patients with acute pancreatitis receiving FFP transfusion.

One poor-quality RCT (Level II) compared FFP treatment with no FFP for patients with liver disease.¹³⁰ The study population comprised 20 patients with liver disease due to paracetamol overdosage. The measured coagulation factor levels were significantly higher in the FFP-treated group; however, the study size precluded detection of any clinically or statistically significant differences in mortality or bleeding events between the two groups. The search did not find any RCTs reporting the incidence of transfusion-related serious adverse events in patients with liver disease receiving FFP transfusion.