guideline critical care bali 2011

7/30/2019 guideline critical care bali 2011

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Rolf Rossaint

Management of the bleeding trauma patient in theICU: A European Guideline

RWTH AachenUniversity


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Financial/Professional RelationshipsConflict of Interest

Lecture and consulting fees from Novo Nordisk

Lecture and consulting fees from BayerHealthcare

Lecture and consulting fees and financialsupport for animal studies from CSL Behring

Lecture and consulting fees from Air Liquide


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ABC-Trauma Guideline Development

Formation of Task Force for Advanced Bleeding Care in Trauma- Cooperation with several European professional societies

European Consensus Guideline Development:- Management of bleeding following major trauma A European

guidelineCritical Care2007, 11:R17Critical Care 2010, 14:R52

Professional societies enforcing the guidelinesEuropean Society for Anaesthesia (ESA)

- European Society for Emergency Medicine (EuSEM)- European Trauma Society (ETS)- European Shock Society (ESS)- European Society for Intensive Care Medicine (ESICM)- European Society of Trauma and Emergency Surgery (ESTES)


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Management of bleeding following majortrauma: an updated European guideline

Rossaint R et al, Crit Care 14:R52, 2010

The guideline consists of 5 parts:

I. Initial resuscitation and prevention of further bleeding

II. Diagnosis and monitoring bleeding

III. Rapid control of Bleeding / Surgical Interventions

IV. ResuscitationTissue oxygenation, fluids and hypothermia

V. Management of bleeding and coagulation


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Management of bleeding following major trauma:an updated European guideline

Fresh Frozen Plasma

We recommend early treatment with thawed fresh frozen

plasma in patients with massive bleeding. (Grade 1B)

The initial recommended dose is 10-15 ml/kg. Further doses

will depend on coagulation monitoring and the amount of

other blood products administered. (Grade 1C).

Recommendation 24


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High Plasma to Red Blood Cell Ratios AreAssociated With Lower Mortality Rates in Trauma

Wafaisade et al, J Trauma 2011


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High Plasma to Red Blood Cell Ratios AreAssociated With Lower Mortality Rates in Trauma

Wafaisade et al, J Trauma 2011


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Platelets

We recommend that platelets be administered to maintain a

platelet count above 50 109/l.(Grade 1C)

We suggest maintenance of a platelet count above 100

109/l in patients with multiple trauma who are severely

bleeding or have traumatic brain injury. (Grade 2C)

We suggest an initial dose of 4-8 platelet concentrates or

one aphaeresis pack. (Grade 2C).

Recommendation 25


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Coagulation support for bleeding complications

Adjunctive treatment options

Antifibrinolytics

- tranexamic acid, -aminocaproic acid

Coagulation factor substitution

Fibrinogen, cryoprecipitates

rFVIIa

Prothrombin complex concentrate (PCC)

Desmopressin

AT III


Rossaint R et al. Crit Care 14:R52 2010


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RCT on the effects of tranexamic acid in trauma

patients with significant haemorrhage (CRASH-2)

CRASH-2 trial collaborators Lancet 2010

1 g over 10 min followed by 1 g over 8hs


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RCT on the effects of tranexamic acid in trauma

patients with significant haemorrhage (CRASH-2)

CRASH-2 trial collaborators Lancet 2010

Conclusion:

Tranexamic acid reduced the risk of death in bleeding traumapatients in this study. On the basis of these results,tranexamicacid should be considered for use in bleeding trauma patients.

M f bl di f ll i j


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Recommendation 27:

Rossaint R et al. Crit Care 14:R52, 2010


Antifibrinolytic Therapy

We suggest that antifibrinolytic agents be considered in the

bleeding trauma patient. (Grade 2C 1B)

We recommend monitoring of fibrinolysis in all patients and

administration of antifibrinolytic agents in patients with

established hyperfibrinolysis. (Grade 1B)

Antifibrinolytic therapy should be guided by thrombelastometricmonitoring if possible and stopped once bleeding has been

adequately controlled. (Grade 2C).


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Antifibrinolytics




rFVIIa


Desmopressin

AT III



Eff t f diff t fib i t ti


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Effects of different fibrinogen concentrations onblood losss and coagulation parameters in a pigmodel of coagulopathy with blunt liver injury

Grottke et al Crit Care 2010

Method:

Coagulopathy in 18 anaesthetized pigs by replacing

80% of blood volume with HAES 130/0.4 and RL

Randomisation:

- Placebo

- 70 mg/kg (F-70) fibrinogen- 200 mg/kg (F-200) fibrinogen

- standardized blunt liver injury

Results:

fibrinogen restored coagulationdose-dependently (ROTEM)

total blood loss was significantly lower

in both fibrinogen groups as compared

to controls (P


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FFP is independently associated with a higherrisk of MOF and ARDS

Watson GA et al; J Trauma 67: 221230; 2009

Method: multicenter prospective cohort study (n=1.175)

M t f bl di f ll i j t


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Management of bleeding following major trauma:an updated European guidelineFibrinogen or cryoprecipitate

We recommend treatment with fibrinogen concentrate orcryoprecipitate if significant bleeding is accompanied by a

plasma fibrinogen level of less than 1.5-2.0 g/l.Grade 1C

We suggest an initial fibrinogen concentrate dose of 34 gor 50 mg/kg of cryoprecipitate approximately equivalent to

1520 units in a 70 kg adult.Grade 1C

Recommendation 26



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Antifibrinolytics




rFVIIa


Desmopressin

AT III




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30d Incidence of MOF, ARDS and death

ITT-population

Incidence(%)

MOF ARDS Death

BLUNT Trauma

0

5

10

15

20

25

30

35

40

Incidence(%)

Placebo

rFVIIa

MOF ARDS Death

PENETRATING Trauma

0

5

10

15

20

25

30

n=7

n=2

n=5n=4

n=18

n=17

p=0.03

n=9

n=5

n=12

n=3

n=22

n=17

Boffard KD et al. J Trauma 2005; 59:8-18


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Efficacy and Safety of rFVIIa in the Management of

Refractory Traumatic Hemorrhage: The CONTROL Trial

Hauser CJ et al. J Trauma 69: 489500 2010


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Efficacy and Safety of rFVIIa in the Management of

Refractory Traumatic Hemorrhage: The CONTROL Trial

Hauser CJ et al. J Trauma 69: 489500, 2010

Clinical Outcomes (30-d ITT Analysis)

Conclusions:rFVIIa reduced blood product use but did not affect mortality

compared with placebo.


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Safety of Recombinant Activated Factor VIIin 35 Randomized Clinical Trials

Levy et al; NEJM363:1791-800 2010

Conclusion:

The risk-benefit considerations should be evaluated

before administering any hemostatic agent.


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We suggest that the use of rFVIIa be

considered if major bleeding in blunt traumapersists despite standard attempts to control

bleeding and best practice use of bloodcomponents.

Grade 2C

Recommendation 28

Management of bleeding following major trauma:

an updated European guideline



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Antifibrinolytics




rFVIIa


Desmopressin

AT III



M t f bl di f ll i j t


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We recommend the use of prothrombin

complex concentrate only for the emergencyreversal of vitamin K-dependent oral

anticoagulants.

Recommendation 29

Grade 1B





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Retrospective analysis of patients receiving >5 RBC/24 hours

N = 131

119 only CFC 12 CFC + FFP (in the ICU)

CFC: coagulation factor concentrates


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Individualised goal directed coagulation therapyusing ROTEM and coagulation factor concentrates

Haemostatic therapy and RBC transfusion

Schchl H et al Crit Care 2010 14:R55


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Individualised Goal directed coagulation therapyusing ROTEM and coagulation factor concentrates

Schchl H et al Crit Care 2010 14:R55

Comparison of the observed

mortality with the mortality

predicted by the trauma

injury severity score (TRISS)

and by the revised injuryseverity classification (RISC)

score


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Key goals for the management of treating thebleeding trauma patient

1. Achieve normothermia2. Achieve normal pH

3. Achieve normal Ca++

4. Treat with FFP, if PT or aPTTabnormal

5. Treat with platelets, if < 100 x 109

6. Treat with fibrinogen, if < 1,5-2.0g/l

7. Treat with antifibrinolytics

(always if hyperfibrinolysis is present)

8. Treat with rFVIIa, if all else fails:- Platelets > 50 x 109

- Fibrinogen > 1 g/l- Hct > 24- pH > 7.2

8 Steps to support coagulation

0.5 1.0 1.5 2.0

Fg

Plt

2.50 0.5 1.0 1.5 2.0 2.5

Blood Volume Replacement

0

Fg?1.0 g l-1

Fg2.0 g l

-1

Hct?2124%Hct2124%

PT, aPTT> 1.5x normalPT, aPTT

Plt< 50x109l-1Plt< 100x1099l-1

Crystalloids

Colloids

RBC

FFP/PCC

Documents

guideline critical care bali 2011