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Open Access

ROTEM®-guided coagulation factor concentrate therapy in trauma: 2-year experience in Venice, Italy

  • Alberto Grassetto1Email author,
  • Marco De Nardin1,
  • Bernadetta Ganzerla1,
  • Monica Geremia1,
  • Debora Saggioro1,
  • Elena Serafini1,
  • Silvia Zampieri1,
  • Manuela Toffoli1,
  • Daniele Penzo1,
  • Antonio Bossi1 and
  • Carlo Maggiolo1
Critical Care201216:428

https://doi.org/10.1186/cc11322

Published: 21 May 2012

Keywords

Trauma PatientCoagulation FactorTranexamic AcidFresh Freeze PlasmaProthrombin Complex Concentrate

Haemostatic therapy for trauma-induced coagulopathy is typically based on administration of allogeneic blood products, although the evidence supporting this approach is poor [1]. Fixed-ratio protocols have been proposed for administering fresh frozen plasma, red blood cells and platelets, but the optimal ratio has not been established and the speed of intervention may be more important [2].

In contrast to fixed-ratio treatment, coagulation factor concentrate therapy guided by point-of-care monitoring allows patients' actual needs to be targeted [3]. Our initial experience with ROTEM ® (Tem International GmbH, Munich, Germany) indicated correlation between the clinical condition and extent of coagulopathy, suggesting a need for the early identification and treatment of coagulopathy that ROTEM ® enables. Altogether, these factors provided a rationale for implementing ROTEM ® -guided therapy for trauma patients in our hospital.

In our experience, this approach is feasible and can replace formula-driven treatment. We found that coagulation factor concentrates (fibrinogen concentrate and prothrombin complex concentrate) correct coagulopathy effectively and rapidly, indicated by normalisation of ROTEM ® parameters among bleeding trauma patients (Table 1). European guidelines for managing trauma raised the target fibrinogen concentration to 1.5 to 2 g/l [4], which we find difficult to reach without using fibrinogen concentrate. Without a comparator group, our data are insufficient to show reduced red blood cell transfusion or improvements in morbidity/mortality. However, we did see a progressive reduction in fresh frozen plasma consumption. Another advantage of using a ROTEM ® -guided approach is the opportunity to detect hyperfibrinolysis. As reported elsewhere, we found that fulminant hyperfibrinolysis is associated with high mortality. Fulminant hyperfibrinolysis may potentially be considered the last gasp of the coagulation system; it may be a marker not only of severe coagulopathy, but also of poor clinical outcome. Our experience also suggests that patients with massive bleeding may benefit from immediate, proactive administration of 1 g tranexamic acid followed by 2 to 4 g fibrinogen concentrate, with further doses as soon as ROTEM ® results are available.
Table 1

Details of bleeding trauma patients receiving ROTEM®-guided coagulation factor concentrate treatment

   

ROTEM® parameters on arrival

 

Haemostatic treatment administered in response to initial ROTEM® assessment

ROTEM® parameters following haemostatic treatment

 
   

EXTEM

 

FIBTEM

     

EXTEM

 

FIBTEM

 
 

ISS on arrival

CT (seconds)

A10 (mm)

MCF (mm)

MCF (mm)

Prothrombin complex concentrate (IU)

Fibrinogen concentrat

Tranexamic acid (g)

Platelet concentrate (U)

CT (seconds)

A10 (mm)

MCF (mm)

MCF (mm)

Outcome

1

25

130

31

44

3

2,000

6

2

0

65

42

54

12

Survived

2

25

75

37

48

5

0

2

0

0

N/A

N/A

N/A

N/A

Survived

3

34

59

54

62

10

0

1

0

0

N/A

N/A

N/A

N/A

Survived

4

43

70

35

43

3

0

3

0

0

40

32

34

10

Surviveda

5

34

95

40

51

7

500

2

0

0

62

42

54

8

Surviveda

6

25

167

18

29

2

1,000

5

2

2

62

39

50

10

Survived

7

66b

216c

14c

22c

0

1,000

7

2

2

59

38

51

13

Diedd

8

66b

139c

22c

34c

0

2,000

8

2

2

74

26

38

8

Diedd

9

34

71

46

56

10

0

3

0

0

61

56

65

14

Survived

10

27

170

20

32

3

1,500

6

2

2

50

39

50

12

Survived

11

45

102

28

37

5

1,500

3

2

1

48

53

63

12

Diedf

12

36

114

20

29

5

1,500

4

2

1

61

39

48

9

Surviveda

A10, clot amplitude (firmness) 10 minutes after clotting time (CT); EXTEM, extrinsically activated thromboelastometric test; FIBTEM, thromboelastometric test of fibrin-based clotting; ISS, injury severity score; IU, international units; MCF, maximum clot firmness; N/A, not available. aPatient received platelets following the second ROTEM ® assessment. bFulminant hyperfibrinolysis was detected, so aprotinin-controlled thromboelastometric test (APTEM) parameters were initially used to guide treatment. Both patients also received fresh frozen plasma after the second ROTEM ® assessment. cValue obtained using the APTEM assay. dCause of death was multiple organ failure. eCause of death was abdominal aortic rupture and unstoppable haemorrhage. fCause of death was brain death.

Fibrinogen concentrate is currently imported in Italy and we use it according to the manufacturer's label. In some countries the product is licensed only for congenital deficiency. However, it is possible to use life-saving drugs for indications beyond the label, providing the physician is convinced that this use is in the patient's best interest; such practice is regulated by health authorities in several countries. High-quality, randomised controlled trials are lacking for both allogeneics and coagulation factor concentrates in trauma, creating a degree of uncertainty with both of these options. Nevertheless, we consider the rationale to be stronger for ROTEM ® -guided, concentrate-based therapy.

Declarations

Acknowledgements

Editorial assistance was provided by medical writers from Meridian HealthComms during the preparation of this manuscript. Financial support for this assistance was provided by CSL Behring.

Authors’ Affiliations

(1)
Dipartimento Emergenza Urgenza, UOC Anestesia e Rianimazione Ospedale dell'Angelo di Mestre,, Venice, Italy

References

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Copyright

© BioMed Central Ltd 2012

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