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Open Access 01-12-2019 | Shock | Editorial
Pre-hospital plasma transfusion: a valuable coagulation support or an expensive fluid therapy?
Published in: Critical Care | Issue 1/2019
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Two recent clinical trials with conflicting results have refuelled the discussion on pre-hospital plasma in trauma. The multicentre, cluster-randomized PAMPer trial assessed the efficacy and safety of two units of pre-hospital plasma versus standard care without plasma in 501 trauma patients at risk for haemorrhagic shock during air medical transport to a designated US trauma centre [1]. The mortality at 30 days was lower in the plasma compared to the standard care group (23% vs 33%; p = 0.03). The randomized, placebo-controlled COMBAT trial compared the same plasma volume versus isotonic saline in 144 haemorrhagic shocked trauma patients within a US ground EMS and a single US trauma centre but mortality at 28 days did not differ between trial groups (15% vs 10%; n.s.) [2]. Table 1 summarizes the basic characteristics of both trials. The results from both trials need to be viewed with caution against their limitations and may not be translated directly into routine without addressing a number of critical issues.
Table 1
Basic characteristics of both trials
|
COMBAT
|
PAMPer
|
|||
|---|---|---|---|---|
|
FFP
|
Standard
|
FFP
|
Standard
|
|
|
Setting
|
US ground EMS transport (Denver) single-centre
|
US air EMS transport multicentre
|
||
|
Randomisation
|
Individual randomisation by content of cooling boxes; staff non-blinded
|
Cluster randomisation at monthly intervals; staff non-blinded
|
||
|
Inclusion criteria
|
BP < 70 mmHg or BP 71–90 mmHg + HR > 108/min
|
BP < 70 mmHg or BP < 90 mmHg and HR > 108/min
|
||
|
Patients included (n)
|
65 vs 60
|
230 vs 271
|
||
|
Age median (IQR)
|
33 (25–51)
|
33 (25–42)
|
44 (31–59)
|
46 (28–60)
|
|
Male (%)
|
80
|
85
|
71
|
74
|
|
Blunt injury (%)
|
46
|
53
|
81
|
73
|
|
Injury severity Score median (IQR)*
|
27 (10–41)
|
27 (11–36)
|
22 (14–33)
|
21 (12–29)
|
|
Prothrombin time ratio or INR on hospital arrival
|
1.3
|
1.2
|
1.2
|
1.3
|
|
Pre-hospital management
|
||||
|
Pre-hospital intubation (%)
|
Not provided
|
Not provided
|
50
|
50
|
|
Pre-hospital RBCs (%)
|
Not provided
|
Not provided
|
26
|
42
|
|
Pre-hospital crystalloids (mls) median (IQR)
|
150 (0–300)
|
250 (100–500)
|
500 (0–1250)
|
900 (0–1500)
|
|
Tranexamic acid within 6 h (%)
|
9
|
13
|
Not provided
|
Not provided
|
|
Intervention
|
2 U pre-thawed FFP up to 5d old FFP vs standard
|
2 U apheresis FFP (approx. 500 ml) vs standard
|
||
|
Median Transportation time median (IQR)
|
28 (22–34) min
|
24 (19–31) min
|
42 (34–53) min
|
40 (33–41) min
|
|
Outcome
|
||||
|
Primary endpoint
|
Mortality 28 days
|
Mortality 30 days
|
||
|
Mortality 28/30d (%)
|
15
|
10
|
23
|
33
|
|
Mortality 24 h (%)
|
12
|
10
|
14
|
22
|