Key messages
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Traumatically injured patients should be transported quickly and treated by a specialised trauma centre whenever possible.
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Measures to monitor and support coagulation should be initiated as early as possible and used to guide a goal-directed treatment strategy.
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A damage-control approach to surgical intervention should guide patient management.
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Coagulation support and thromboprophylactic strategies should consider trauma patients who have been pre-treated with anticoagulants or platelet inhibitors.
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Local adherence to a multidisciplinary, evidence-based treatment protocol should serve as the basis of patient management and undergo regular quality assessment.
Background
Methods
Grade of recommendation | Clarity of risk/benefit | Quality of supporting evidence | Implications |
---|---|---|---|
1A | |||
Strong recommendation, high-quality evidence | Benefits clearly outweigh risk and burdens, or vice versa | RCTs without important limitations or overwhelming evidence from observational studies | Strong recommendation, can apply to most patients in most circumstances without reservation |
1B | |||
Strong recommendation, moderate-quality evidence | Benefits clearly outweigh risk and burdens, or vice versa | RCTs with important limitations (inconsistent results, methodological flaws, indirect or imprecise) or exceptionally strong evidence from observational studies | Strong recommendation, can apply to most patients in most circumstances without reservation |
1C | |||
Strong recommendation, low-quality or very low-quality evidence | Benefits clearly outweigh risk and burdens, or vice versa | Observational studies or case series | Strong recommendation but may change when higher quality evidence becomes available |
2A | |||
Weak recommendation, high-quality evidence | Benefits closely balanced with risks and burden | RCTs without important limitations or overwhelming evidence from observational studies | Weak recommendation, best action may differ depending on circumstances or patients’ or societal values |
2B | |||
Weak recommendation, moderate-quality evidence | Benefits closely balanced with risks and burden | RCTs with important limitations (inconsistent results, methodological flaws, indirect or imprecise) or exceptionally strong evidence from observational studies | Weak recommendation, best action may differ depending on circumstances or patients’ or societal values |
2C | |||
Weak recommendation, low-quality or very low-quality evidence | Uncertainty in the estimates of benefits, risks, and burden; benefits, risk and burden may be closely balanced | Observational studies or case series | Very weak recommendation; other alternatives may be equally reasonable |
Question | Step 1 (level 1*) | Step 2 (level 2*) | Step 3 (level 3*) | Step 4 (level 4*) | Step 5 (level 5) |
---|---|---|---|---|---|
How common is the problem? | Local and current random sample surveys (or censuses) | Systematic review of surveys that allow matching to local circumstances** | Local non-random sample** | Case-series** | N/A |
Is this diagnostic or monitoring test accurate? (diagnosis) | Systematic review of cross-sectional studies with consistently applied reference standard and blinding | Individual cross-sectional studies with consistently applied reference standard and blinding | Non-consecutive studies or studies without consistently applied reference standards** | Case-control studies or poor or non-independent reference standard** | Mechanism-based reasoning |
What will happen if we do not add a therapy? (prognosis) | Systematic review of inception cohort studies | Inception cohort studies | Cohort study or control arm of randomised trial* | Case-series or case-control studies or poor-quality prognostic cohort study** | N/A |
Does this intervention help? (treatment benefits) | Systematic review of randomised trials or n-of-1 trials | Randomised trial or observational study with dramatic effect | Non-randomised controlled cohort/follow-up study** | Case-series, case-control studies or historically controlled studies** | Mechanism-based reasoning |
What are the common harms? (treatment harms) | Systematic review of randomised trials, systematic review of nested case-control studies, n-of-1 trial with the patient you are raising the question about, or observational study with dramatic effect | Individual randomised trial or (exceptionally) observational study with dramatic effect | Non-randomised controlled cohort/follow-up study (post-marketing surveillance) provided there are sufficient numbers to rule out a common harm. (For long-term harms the duration of follow-up must be sufficient.)** | Case-series, case-control or historically controlled studies** | Mechanism-based reasoning |
What are the rare harms? (treatment harms) | Systematic review of randomised trials or n-of-1 trial | Randomised trial or (exceptionally) observational study with dramatic effect | |||
Is this (early detection) test worthwhile? (screening) | Systematic review of randomised trials | Randomised trial | Non-randomised controlled cohort/follow-up study** | Case-series, case-control or historically controlled studies** | Mechanism-based reasoning |
Results
I. Initial resuscitation and prevention of further bleeding
Minimal elapsed time
Rationale
Local bleeding management
Rationale
Ventilation
Rationale
II. Diagnosis and monitoring of bleeding
Initial assessment
Rationale
Parameter | Class I | Class II (mild) | Class III (moderate) | Class IV (severe) |
---|---|---|---|---|
Approximate blood loss | < 15% | 15–30% | 31–40% | > 40% |
Heart rate | ↔ | ↔ / ↑ | ↑ | ↑ / ↑↑ |
Blood pressure | ↔ | ↔ | ↔ / ↓ | ↓ |
Pulse pressure | ↔ | ↓ | ↓ | ↓ |
Respiratory rate | ↔ | ↔ | ↔ / ↑ | ↑ |
Urine output | ↔ | ↔ | ↓ | ↓↓ |
Glasgow Coma Scale score | ↔ | ↔ | ↓ | ↓ |
Base deficit* | 0 to − 2 mEq/L | – 2 to −6 mEq/L | – 6 to −10 mEq/L | – 10 mEq/L or less |
Need for blood products | Monitor | Possible | Yes | Massive transfusion protocol |
Immediate intervention
Rationale
Further investigation
Rationale
Imaging
Rationale
Haemoglobin
Rationale
Serum lactate and base deficit
Rationale
Coagulation monitoring
Rationale
Platelet function monitoring
Rationale
III. Tissue oxygenation, volume, fluids and temperature
Tissue oxygenation
Restricted volume replacement
Vasopressors and inotropic agents
Rationale
Type of fluid
Rationale
Erythrocytes
Rationale
Temperature management
Rationale
IV. Rapid control of bleeding
Damage-control surgery
Rationale
Pelvic ring closure and stabilisation
Packing, embolisation and surgery
Rationale
Local haemostatic measures
Rationale
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Collagen-based agents trigger platelet aggregation, resulting in clot formation when in contact with a bleeding surface. They are often combined with a procoagulant substance such as thrombin to enhance the haemostatic effect. A positive haemostatic effect has been shown in several human studies [471, 479, 480, 485].
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Gelatine-based products can be used alone or in combination with a procoagulant substance [470]. Swelling of the gelatine in contact with blood reduces the blood flow and, in combination with a thrombin-based component, enhances haemostasis [476, 477, 482]. These products have been successfully used for local bleeding control in brain or thyroid surgery when electrocautery may cause damage to nerves [481] or to control bleeding from irregular surfaces such as during post-sinus surgery [484].
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Absorbable cellulose-based haemostatic agents have been widely used to treat bleeding for many years, and case reports as well as a prospective observational human study support their effectiveness [483]. The oxidised cellulose-based product can be impregnated with polyethylene glycol and other salts and achieve comparable and more rapid haemostasis compared to the combined products described below [475].
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Polysaccharide-based haemostatics can be divided into two broad categories [470]: N-acetyl-glucosamine-containing glycosaminoglycans purified from microalgae and diatoms, and microporous polysaccharide haemospheres produced from potato starch. Some minerals, such as kaolin, also seem to have haemostatic effects. The mechanism of action is complex and depends on the purity or combination with other substances such as cellulose or fibrin. A number of different products in the form of pads, patches or bandages are currently available and have been shown to be efficient for external use and for splanchnic bleeding. Observational studies have shown that haemorrhage control is achieved using a poly-N-acetyl glucosamine- or kaolin-based bandage applied to patients with severe hepatic and abdominal injuries, acidosis and clinical coagulopathy [480, 486].
V. Initial management of bleeding and coagulopathy
Antifibrinolytic agents
Rationale
Coagulation support
Rationale
Initial coagulation resuscitation
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FFP or pathogen-inactivated FFP in a FFP:RBC ratio of at least 1:2 as needed. (Grade 1C)
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Fibrinogen concentrate and RBC. (Grade 1C)
Rationale
VI. Further goal-directed coagulation management
Goal-directed therapy
Rationale
Fresh frozen plasma-based management
Rationale
Coagulation factor concentrate-based management
Rationale
Fibrinogen supplementation
Rationale
Platelets
Rationale
Calcium
Rationale
Recombinant activated coagulation factor VII
Rationale
VII. Reversal of antithrombotic agents
Antithrombotic agent reversal
Rationale
Reversal of vitamin K-dependent oral anticoagulants
Rationale
Direct oral anticoagulants—factor Xa inhibitors
Direct oral anticoagulants—direct thrombin inhibitors
Rationale
Antiplatelet agents
Rationale
VIII. Thromboprophylaxis
Thromboprophylaxis
Rationale
IX. Guideline implementation and quality control
Guideline implementation
Assessment of bleeding control and outcome
Rationale
Treatment phase | Yes | No | N/A | Reason for variance |
---|---|---|---|---|
Initial assessment and management | ||||
Extent of traumatic haemorrhage assessed | ☐ | ☐ | ☐ | |
Patient in shock with identified source of bleeding treated immediately | ☐ | ☐ | ☐ | |
Patient in shock with unidentified source of bleeding sent for further investigation | ☐ | ☐ | ☐ | |
Coagulation, haematocrit, serum lactate, base deficit assessed | ☐ | ☐ | ☐ | |
Antifibrinolytic therapy initiated | ☐ | ☐ | ☐ | |
Patient history of anticoagulant therapy assessed (vitamin K antagonists, antiplatelet agents, oral anticoagulants) | ☐ | ☐ | ☐ | |
Resuscitation | ||||
Systolic blood pressure of 80–90 mmHg achieved in absence of TBI | ☐ | ☐ | ☐ | |
Measures to achieve normothermia implemented | ☐ | ☐ | ☐ | |
Target Hb level 70–90 g/L achieved | ☐ | ☐ | ☐ | |
Surgical intervention | ||||
Abdominal bleeding control achieved | ☐ | ☐ | ☐ | |
Pelvic ring closed and stabilised | ☐ | ☐ | ☐ | |
Peritoneal packing, angiographic embolisation or surgical bleeding control completed in haemodynamically unstable patient | ☐ | ☐ | ☐ | |
Damage-control surgery performed in haemodynamically unstable patient | ☐ | ☐ | ☐ | |
Local haemostatic measures applied | ☐ | ☐ | ☐ | |
Thromboprophylactic therapy recommended | ☐ | ☐ | ☐ | |
Coagulation management | ||||
Coagulation, haematocrit, serum lactate, base deficit, calcium reassessed | ☐ | ☐ | ☐ | |
Target fibrinogen level 1.5–2 g/L achieved | ☐ | ☐ | ☐ | |
Target platelet level achieved | ☐ | ☐ | ☐ | |
Prothrombin complex concentrate administered if indicated due to vitamin K antagonist, oral anticoagulant or evidence from viscoelastic methods | ☐ | ☐ | ☐ |
Pre-hospital bundle | Intra-hospital bundle | Coagulation bundle |
---|---|---|
• Pre-hospital time minimised • Tourniquet employed in case of life-threatening bleeding from extremities • Damage-control resuscitation concept applied • Trauma patient transferred directly to an adequate trauma specialty centre | • Full blood count, PT, fibrinogen, calcium, viscoelastic testing, lactate, BE and pH assessed within the first 15 min • Immediate intervention applied in patients with haemorrhagic shock and an identified source of bleeding unless initial resuscitation measures are successful • Immediate further investigation undertaken using FAST, CT or immediate surgery if massive intra-abdominal bleeding is present in patients presenting with haemorrhagic shock and an unidentified source of bleeding • Damage-control surgery concept applied if shock or coagulopathy are present • Damage-control resuscitation concept continued until the bleeding source is identified and controlled • Restrictive erythrocyte transfusion strategy (Hb 70–90 g/L) applied | • Tranexamic acid administered as early as possible • Acidosis, hypothermia and hypocalcaemia treated • Fibrinogen maintained at 1.5–2 g/L • Platelets maintained at > 100 × 109/L • Prothrombin complex concentrate administered in patients pre-treated with warfarin or direct-acting oral coagulants (until antidotes are available) |
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Time from injury to the initiation of intervention to stop bleeding (surgery or embolisation) in hypotensive patients who do not respond to initial resuscitation
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Time from hospital arrival to availability of a full set of blood results [full blood count, PT, fibrinogen, calcium, viscoelastic testing (if available)]
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Proportion of patients receiving TXA within 3 h after injury
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Time from hospital arrival to CT scan in bleeding patients without an obvious source of haemorrhage
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Damage-control surgical techniques used in accordance with R18
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Thromboprophylaxis commenced in accordance with R37
Discussion
Conclusions
Acknowledgements
Funding
Availability of data and materials
Authors’ information
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RR serves as chair of the Advanced Bleeding Care in Trauma (ABC-T) European Medical Education Initiative.
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DRS serves as co-chair of the ABC-T European Medical Education Initiative.
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BB is a member of the ABC-T European Medical Education Initiative faculty.
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VC is a member of the ABC-T European Medical Education Initiative faculty.
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JD represented the European Society of Intensive Care Medicine (ESICM) on the ABC-T Task Force.
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DF represented the European Society of Anaesthesiology (ESA) on the ABC-T Task Force.
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MM represented the European Shock Society (ESS) on the ABC-T Task Force.
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GN is a member of the ABC-T European Medical Education Initiative faculty.
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BJH is a member of the ABC-T European Medical Education Initiative faculty.
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RK represented the European Society of Trauma and Emergency Surgery (ESTES) on the ABC-T Task Force.
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LR represented the European Society for Emergency Medicine (EuSEM) on the ABC-T Task Force.
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CMS represented the Network for the Advancement of Patient Blood Management, Haemostasis and Thrombosis (NATA) on the ABC-T Task Force.
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JLV is a member of the ABC-T European Medical Education Initiative faculty.
Ethics approval and consent to participate
Consent for publication
Competing interests
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In the past 5 years, DRS’s academic department has received grant support from the Swiss National Science Foundation, Berne, Switzerland, the Ministry of Health (Gesundheitsdirektion) of the Canton of Zurich, Switzerland for Highly Specialized Medicine, the Swiss Society of Anesthesiology and Reanimation (SGAR), Berne, Switzerland, the Swiss Foundation for Anesthesia Research, Zurich, Switzerland, CSL Behring, Berne, Switzerland, Vifor SA, Villars-sur-Glâne, Switzerland. DRS is co-chair of the ABC-Trauma Faculty, sponsored by unrestricted educational grants from Novo Nordisk Health Care AG, Zurich, Switzerland, CSL Behring GmbH, Marburg, Germany, LFB Biomédicaments, Courtaboeuf Cedex, France and Octapharma AG, Lachen, Switzerland. DRS received honoraria or travel support for consulting or lecturing from: Danube University of Krems, Austria, US Department of Defense, Washington, USA, European Society of Anesthesiology, Brussels, BE, Korea, Korean Society for Patient Blood Management, Seoul, Korea, Korean Society of Anesthesiologists, Seoul, Baxter AG, Volketswil, Switzerland, Baxter S.p.A., Roma, Italy, Bayer AG, Zürich, Switzerland, Bayer Pharma AG, Berlin, Germany, B. Braun Melsungen AG, Melsungen, Germany, Boehringer Ingelheim GmbH, Basel, Switzerland, Bristol-Myers-Squibb, Rueil-Malmaison Cedex, France and Baar, Switzerland, CSL Behring GmbH, Hattersheim am Main, Germany and Berne, Switzerland, Celgene International II Sàrl, Couvet, Switzerland, Curacyte AG, Munich, Germany, Daiichi Sankyo AG, Thalwil, Switzerland, GlaxoSmithKline GmbH & Co. KG, Hamburg, Germany, Haemonetics, Braintree, MA, USA, Instrumentation Laboratory (Werfen), Bedford, MA, USA, LFB Biomédicaments, Courtaboeuf Cedex, France, Merck Sharp & Dohme, Kenilworth, New Jersey, USA, Octapharma AG, Lachen, Switzerland, Organon AG, Pfäffikon/SZ, Switzerland, PAION Deutschland GmbH, Aachen, Germany, Pharmacosmos A/S, Holbaek, Denmark, Photonics Healthcare B.V., Utrecht, Netherlands, Roche Diagnostics International Ltd., Reinach, Switzerland, Roche Pharma AG, Reinach, Switzerland, Sarstedt AG & Co., Sevelen, Switzerland and Nümbrecht, Germany Schering-Plough International, Inc., Kenilworth, New Jersey, USA, Tem International GmbH, Munich, Germany, Verum Diagnostica GmbH, Munich, Germany, Vifor Pharma, Munich, Germany, Vienna, Austria and Villars-sur-Glâne, Switzerland, Vifor (International) AG, St. Gallen.
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BB has no competing interests to declare.
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In the past 5 years, VC has received honoraria for consulting or lecturing from CSL Behring, AbbVie, BBraun, Bard. VC reports research grant funding from the Czech Health Research Council, Czech Republic, and the Charles University Faculty of Medicine in Hradec Kralove, Czech Republic. VC has received institutional support from the Charles University Faculty of Medicine in Hradec Kralove, Czech Republic, the University Hospital Hradec Kralove, Czech Republic and Masaryk Hospital Usti nad Labem, Czech Republic.
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In the past 5 years, JD has received honoraria for lecturing from LFB Biomédicaments.
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In the past 5 years, DF has received honoraria for lecturing from the following companies and organisations: Romanian Society of Cardiology, MedLife Health System and Danube University of Krems, Austria. DF has received institutional support from Vifor Pharma, Siramed SRL and Synttergy Consult SRL.
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In the past 5 years, BJH has received research grant funding from CSL Behring.
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In the past 5 years, RK has received honoraria for lecturing from CSL Behring.
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In the past 5 years, MM has received honoraria for consulting or lecturing from Astra Zeneca, Bayer, Biotest, CSL Behring, IL Werfen/TEM International, LFB Biomedicaments France and has received research grant funding from CSL Behring.
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In the past 5 years, GN has received honoraria for lecturing from CSL Behring.
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LR has no competing interests to declare.
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In the past 5 years, CMS has received honoraria for consulting or lecturing from Aspen, Daiichi-Sankyo, Medtronic, Roche, BMS, Pfizer, Bayer, Stago, Siemens, Octapharma, LFB Biomédicaments and has received research grant funding from Haemonetics.
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JLV has no competing interests to declare.
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In the past 5 years, RR has received honoraria for consulting or lecturing from CSL Behring, Boehringer Ingelheim and Fresenius. In fields related to this work RR or his co-workers received research grant funding from DFG, Bayer, Biotest, Boehringer Ingelheim, CSL Behring, Novo Nordisk and Nycomed.