The European guideline on management of major bleeding and coagulopathy following trauma: sixth edition

Task Force for Advanced Bleeding Care in… · 2023 · Europe

Source and licence

Authors
Rolf Rossaint, Arash Afshari, Bertil Bouillon et al.
Title
The European guideline on management of major bleeding and coagulopathy following trauma: sixth edition
Journal
Critical Care, 2023
Licence
CC BY 4.0
Changes
Verbatim excerpts; formatting adapted

Full text retrieved 2026-10-27 from Europe PMC · PMC9977110

Licence statement of the original publication

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This page reproduces excerpts of the original publication; the original is authoritative. It has not been reviewed by a physician, does not state a recommendation of Medelix and does not replace medical advice. The guideline may have been updated since.

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Recommendations

Verbatim, with grade of recommendation or strength of consensus where given.

Minimal elapsed time

  • Recommendation 1We recommend that severely injured patients be transported directly to an appropriate trauma facilityGrade 1B

Recommendation 1

  • We recommend that the time elapsed between injury and bleeding control be minimisedGrade 1B

Local bleeding management

  • Recommendation 2We recommend local compression of open wounds to limit life-threatening bleedingGrade 1B

Recommendation 2

  • We recommend adjunct tourniquet use to stop life-threatening bleeding from open extremity injuries in the pre-surgical settingGrade 1B

Ventilation

  • Recommendation 3We recommend that endotracheal intubation or alternative airway management be performed without delay in the presence of airway obstruction, altered consciousness [Glasgow Coma Scale (GCS) ≤ 8], hypoventilation or hypoxaemiaGrade 1B

Recommendation 3

  • We recommend the avoidance of hypoxaemiaGrade 1A
  • We suggest the avoidance of hyperoxaemia, except in the presence of imminent exsanguinationGrade 2B
  • We recommend normoventilation of trauma patientsGrade 1B
  • We suggest hyperventilation as a life-saving measure in the presence of signs of cerebral herniationGrade 2C

Pre-hospital blood product use

  • Recommendation 4No clear recommendation or suggestion in favour or against the use of pre-hospital blood products can be provided at this time.

Initial assessment

  • Recommendation 5We recommend that the physician clinically assess the extent of traumatic haemorrhage using a combination of patient physiology, anatomical injury pattern, mechanism of injury and the patient response to initial resuscitationGrade 1C

Recommendation 5

  • We recommend that the shock index (SI) and/or pulse pressure (PP) be used to assess the degree of hypovolaemic shock and transfusion requirementsGrade 1C

Immediate intervention

  • Recommendation 6We recommend that patients with an obvious bleeding source and those presenting with haemorrhagic shock in extremis and a suspected source of bleeding undergo an immediate bleeding control procedureGrade 1B

Further investigation

  • Recommendation 7We recommend that patients with an unidentified source of bleeding, but without a need for immediate bleeding control, undergo immediate further investigation to determine the bleeding sourceGrade 1C

Imaging

  • Recommendation 8We suggest the use of pre-hospital ultrasonography (PHUS) for the detection of haemo-/pneumothorax, haemopericardium and/or free abdominal fluid in patients with thoracoabdominal injuries, if feasible without delaying transportGrade 2B

Recommendation 8

  • We recommend the use of point-of-care ultrasonography (POCUS), including FAST, in patients with thoracoabdominal injuriesGrade 1C
  • We recommend early imaging using contrast-enhanced whole-body CT (WBCT) for the detection and identification of the type of injury and the potential source of bleedingGrade 1B

Haemoglobin

  • Recommendation 9We recommend the use of repeated Hb and/or Hct measurements as a laboratory marker for bleeding, as an initial value in the normal range may mask early-phase bleedingGrade 1B

Blood lactate and base deficit

  • Recommendation 10We recommend blood lactate as a sensitive test to estimate and monitor the extent of bleeding and tissue hypoperfusion; in the absence of lactate measurements, base deficit may represent a suitable alternativeGrade 1B

Coagulation monitoring

  • Recommendation 11We recommend the early and repeated monitoring of haemostasis, using either a traditional laboratory determination such as prothrombin time (PT)/international normalised ratio (INR), Clauss fibrinogen level and platelet count and/or point-of-care (POC) PT/INR and/or a viscoelastic methodGrade 1C

Platelet function monitoring

  • Recommendation 12We recommend that the routine use of POC platelet function devices for platelet function monitoring in trauma patients on antiplatelet therapy or with suspected platelet dysfunction be avoidedGrade 1C

Volume replacement and target blood pressure

  • Recommendation 13In the initial phase following trauma, we recommend the use of a restricted volume replacement strategy with a target systolic blood pressure of 80–90 mmHg (mean arterial pressure 50–60 mmHg) until major bleeding has been stopped without clinical evidence of brain injuryGrade 1B

Recommendation 13

  • In patients with severe TBI (GCS ≤ 8), we recommend that a mean arterial pressure ≥ 80 mmHg be maintainedGrade 1C

Vasopressors and inotropic agents

  • Recommendation 14If a restricted volume replacement strategy does not achieve the target blood pressure, we recommend the administration of noradrenaline in addition to fluids to maintain target arterial pressureGrade 1C

Recommendation 14

  • We recommend infusion of dobutamine in the presence of myocardial dysfunctionGrade 1C

Type of fluid

  • Recommendation 15We recommend that fluid therapy using a 0.9% sodium chloride or balanced crystalloid solution be initiated in the hypotensive bleeding trauma patientGrade 1B

Recommendation 15

  • We recommend that hypotonic solutions such as Ringer’s lactate be avoided in patients with severe head traumaGrade 1B
  • We recommend that the use of colloids be restricted due to the adverse effects on haemostasisGrade 1C

Erythrocytes

  • Recommendation 16If erythrocyte transfusion is necessary, we recommend a target haemoglobin of 70–90 g/LGrade 1C

Cell salvage

  • Recommendation 17We suggest that cell salvage be considered in the presence of severe bleeding from an abdominal, pelvic or thoracic cavityGrade 2B

Temperature management

  • Recommendation 18We recommend early application of measures to reduce heat loss and warm the hypothermic patient to achieve and maintain normothermiaGrade 1C

Damage control surgery

  • Recommendation 19We recommend damage control surgery in the severely injured patient presenting with haemorrhagic shock, signs of ongoing bleeding, coagulopathy and/or combined abdominal vascular and pancreatic injuriesGrade 1B

Recommendation 19

  • Other factors that should trigger a damage control approach are hypothermia, acidosis, inaccessible major anatomic injury, a need for time-consuming proceduresGrade 1C
  • We recommend primary definitive surgical management in the absence of any of the factors aboveGrade 1C

Pelvic ring closure and stabilisation

  • Recommendation 20We recommend the adjunct use of a pelvic binder in the pre-hospital setting to limit life-threatening bleeding in the presence of a suspected pelvic fractureGrade 1C

Recommendation 20

  • We recommend that patients with pelvic ring disruption in haemorrhagic shock undergo pelvic ring closure and stabilisation as early as possibleGrade 1B

Embolisation, packing, surgery and resuscitative endovascular balloon occlusion of the aorta (REBOA)

  • Recommendation 21We recommend temporary extra-peritoneal packing when bleeding is ongoing and/or when angioembolisation cannot be achieved in a timely manner. Extra-peritoneal packing can be combined with open abdominal surgery when necessaryGrade 1C

Recommendation 21

  • We suggest that REBOA be considered in patients with noncompressible life-threatening traumatic haemorrhage to bridge the gap between haemodynamic collapse and haemorrhage controlGrade 2C

Local haemostatic measures

  • Recommendation 22We recommend the use of topical haemostatic agents in combination with other surgical measures or with packing for venous or moderate arterial bleeding associated with parenchymal injuriesGrade 1B

Antifibrinolytic agents

  • Recommendation 23We recommend that tranexamic acid (TXA) be administered to the trauma patient who is bleeding or at risk of significant bleeding as soon as possible, if feasible en route to the hospital, and within 3 h after injury at a loading dose of 1 g infused over 10 min, followed by an i.v. infusion of 1 g over 8 hGrade 1A

Recommendation 23

  • We recommend that the administration of TXA not await results from a viscoelastic assessmentGrade 1B

Coagulation support

  • Recommendation 24We recommend that monitoring and measures to support coagulation be initiated immediately upon hospital admissionGrade 1B

Initial coagulation resuscitation

  • Recommendation 25In the initial management of patients with expected massive haemorrhage, we recommend one of the two following strategies: Fibrinogen concentrate or cryoprecipitate and pRBC (Grade 1C) FFP or pathogen-inactivated FFP in a FFP/pRBC ratio of at least 1:2 as neededGrade 1C

Recommendation 25

  • In addition, we suggest a high platelet/pRBC ratioGrade 2B

Goal-directed therapy

  • Recommendation 26We recommend that resuscitation measures be continued using a goal-directed strategy, guided by standard laboratory coagulation values and/or VEMGrade 1B

Fresh frozen plasma-based management

  • Recommendation 27If a FFP-based coagulation resuscitation strategy is used, we recommend that further use of FFP be guided by standard laboratory coagulation screening parameters (PT and/or APTT > 1.5 times normal and/or viscoelastic evidence of a coagulation factor deficiency)Grade 1C

Recommendation 27

  • We recommend that the use of FFP be avoided for the correction of hypofibrinogenemia if fibrinogen concentrate and/or cryoprecipitate are availableGrade 1C

Coagulation factor concentrate-based management

  • Recommendation 28If a CFC-based strategy is used, we recommend treatment with factor concentrates based on standard laboratory coagulation parameters and/or viscoelastic evidence of a functional coagulation factor deficiencyGrade 1C

Recommendation 28

  • Provided that fibrinogen levels are normal, we suggest that prothrombin complex concentrate (PCC) is administered to the bleeding patient based on evidence of delayed coagulation initiation using VEMGrade 2C
  • We suggest that monitoring of FXIII be included in coagulation support algorithms and that FXIII be supplemented in bleeding patients with a functional FXIII deficiencyGrade 2C

Fibrinogen supplementation

  • Recommendation 29We recommend treatment with fibrinogen concentrate or cryoprecipitate if major bleeding is accompanied by hypofibrinogenemia (viscoelastic signs of a functional fibrinogen deficit or a plasma Clauss fibrinogen level ≤ 1.5 g/L) (Grade 1C)*

Recommendation 29

  • We suggest an initial fibrinogen supplementation of 3–4 g. This is equivalent to 15–20 single donor units of cryoprecipitate or 3–4 g fibrinogen concentrate. Repeat doses should be guided by VEM and laboratory assessment of fibrinogen levelsGrade 2C

Platelets

  • Recommendation 30We suggest that platelets be administered to maintain a platelet count above 50 × 109/L in trauma patients with ongoing bleeding and above 100 × 109/L in patients with TBIGrade 2C

Recommendation 30

  • If administered, we suggest an initial dose of four to eight single platelet units or one aphaeresis packGrade 2B

Calcium

  • Recommendation 31We recommend that ionised calcium levels be monitored and maintained within the normal range following major trauma and especially during massive transfusionGrade 1C

Recommendation 31

  • We recommend the administration of calcium chloride to correct hypocalcaemiaGrade 1C

Recombinant activated coagulation factor VII

  • Recommendation 32We do not recommend the use of recombinant activated coagulation factor VII (rFVIIa) as first-line treatmentGrade 1B

Recommendation 32

  • We suggest that the off-label use of rFVIIa be considered only if major bleeding and traumatic coagulopathy persist despite all other attempts to control bleeding, systemic homeostasis and best-practice use of conventional haemostatic measuresGrade 2C

Reversal of vitamin K-dependent oral anticoagulants

  • Recommendation 33In the bleeding trauma patient, we recommend the emergency reversal of vitamin K-dependent oral anticoagulants with the early use of both PCC and 5–10 mg i.v. phytomenadione (vitamin K1)Grade 1A

Rationale

  • We recommend a 5–10 mg dose of vitamin K because less may not fully correct the INR and conversely more than 10 mg vitamin K1 can prevent re-warfarinisation for days and may create a prothrombotic state, which could lead to further thromboembolism [339].

Management of direct oral anticoagulants—factor Xa inhibitors

  • Recommendation 34We suggest the measurement of plasma levels of oral direct antifactor Xa agents such as apixaban, edoxaban or rivaroxaban in patients treated or suspected of being treated with one of these agentsGrade 2C

Recommendation 34

  • We suggest that measurement of anti-Xa activity be calibrated for the specific agent. If not possible or available, we suggest low molecular weight heparin (LMWH)-calibrated anti-Xa assays as a reliable alternativeGrade 2C
  • If bleeding is life-threatening in the presence of an apixaban or rivaroxaban effect, especially in patients with TBI, we suggest reversal with andexanet alfaGrade 2C
  • If andexanet alfa is not available, or in patients receiving edoxaban, we suggest the administration of PCC (25–50 U/kg)Grade 2C

Management of direct oral anticoagulants—direct thrombin inhibitors

  • Recommendation 35We suggest the measurement of dabigatran plasma levels using diluted thrombin time in patients treated or suspected of being treated with dabigatranGrade 2C

Recommendation 35

  • If measurement is not possible or available, we suggest measurement of the standard thrombin time to allow a qualitative estimation of the presence of dabigatranGrade 2C
  • If bleeding is life-threatening in those receiving dabigatran, we recommend treatment with idarucizumab (i.v. 5 g)Grade 1C

Antiplatelet agents

  • Recommendation 36We recommend that routine platelet transfusion be avoided in patients with ongoing bleeding who have been treated with APAsGrade 1C

Thromboprophylaxis

  • Recommendation 37We recommend early initiation of mechanical thromboprophylaxis with intermittent pneumatic compression (IPC) while the patient is immobile and has a bleeding riskGrade 1C

Recommendation 37

  • We recommend combined pharmacological and IPC thromboprophylaxis within 24 h after bleeding has been controlled and until the patient is mobileGrade 1B
  • We do not recommend the use of graduated compression stockings for thromboprophylaxisGrade 1C
  • We do not recommend the routine use of inferior vena cava filters as thromboprophylaxisGrade 1C

Guideline implementation

  • Recommendation 38We recommend the local implementation of evidence-based guidelines for management of the bleeding trauma patientGrade 1B

Assessment of bleeding control and outcome

  • Recommendation 39We recommend that local clinical quality and safety management systems include parameters to assess key measures of bleeding control and outcomeGrade 1B

Abstract

Background: Severe trauma represents a major global public health burden and the management of post-traumatic bleeding continues to challenge healthcare systems around the world. Post-traumatic bleeding and associated traumatic coagulopathy remain leading causes of potentially preventable multiorgan failure and death if not diagnosed and managed in an appropriate and timely manner. This sixth edition of the European guideline on the management of major bleeding and coagulopathy following traumatic injury aims to advise clinicians who care for the bleeding trauma patient during the initial diagnostic and therapeutic phases of patient management.

Methods: The pan-European, multidisciplinary Task Force for Advanced Bleeding Care in Trauma included representatives from six European professional societies and convened to assess and update the previous version of this guideline using a structured, evidence-based consensus approach. Structured literature searches covered the period since the last edition of the guideline, but considered evidence cited previously. The format of this edition has been adjusted to reflect the trend towards concise guideline documents that cite only the highest-quality studies and most relevant literature rather than attempting to provide a comprehensive literature review to accompany each recommendation.

Results: This guideline comprises 39 clinical practice recommendations that follow an approximate temporal path for management of the bleeding trauma patient, with recommendations grouped behind key decision points. While approximately one-third of patients who have experienced severe trauma arrive in hospital in a coagulopathic state, a systematic diagnostic and therapeutic approach has been shown to reduce the number of preventable deaths attributable to traumatic injury.

Conclusion: A multidisciplinary approach and adherence to evidence-based guidelines are pillars of best practice in the management of severely injured trauma patients. Further improvement in outcomes will be achieved by optimising and standardising trauma care in line with the available evidence across Europe and beyond.

Supplementary Information: The online version contains supplementary material available at 10.1186/s13054-023-04327-7.

Contents of the original publication

The section headings of the original.

  • Background
  • Methods
  • Results
  • I. Initial resuscitation and prevention of further bleeding
  • II. Diagnosis and monitoring of bleeding
  • III. Tissue oxygenation, volume, fluids and temperature
  • IV. Rapid control of bleeding
  • V. Initial management of bleeding and coagulopathy
  • VI. Further goal-directed coagulation management
  • VII. Management of antithrombotic agents
  • VIII. Thromboprophylaxis
  • IX. Guideline implementation and quality control
  • Discussion

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