Implementation of health-related quality of life in the German TraumaRegister DGU® - first results of a pilot study.

BACKGROUND: Approximately 30,000 people are affected by severe injuries in Germany each year. Continuous progress in prehospital and hospital care has significantly reduced the mortality of polytrauma patients. With increasing survival rates, the functional outcome, health-related quality (hrQoL) of life and ability to work are now gaining importance. Aim of the study is, the presentation of the response behavior of seriously injured patients on the one hand and the examination of the factors influencing the quality of life and ability to work 12 months after major trauma on the other hand. Building on these initial results, a standard outcome tool shall be integrated in the established TraumaRegister DGU® in the future. METHODS: In 2018, patients [Injury Severity Score (ISS) ≥ 16; age:18-75 years] underwent multicenter one-year posttraumatic follow-up in six study hospitals. In addition to assessing hrQoL by using the Short-Form Health Survey (SF-12), five additional questions (treatment satisfaction; ability to work; trauma-related medical treatment; relevant physical disability, hrQoL as compared with the prior to injury status) were applied. RESULTS: Of the 1,162 patients contacted, 594 responded and were included in the analysis. The post-injury hrQoL does not show statistically significant differences between the sexes. Regarding age, however, the younger the patient at injury, the better the SF-12 physical sum score. Furthermore, the physically perceived quality of life decreases statistically significantly in relation to the severity of the trauma as measured by the ISS, whereas the mentally perceived quality of life shows no differences in terms of injury severity. A large proportion of severely injured patients were very satisfied (42.2%) or satisfied (39.9%) with the treatment outcome. It should be emphasized that patients with a high injury severity (ISS > 50) were on average more often very satisfied with the treatment outcome (46.7%). A total of 429 patients provided information on their ability to work 12 months post-injury. Here, 194 (45.2%) patients had a full employment, and 58 (13.5%) patients were had a restricted employment. CONCLUSION: The present results show the importance of a structured assessment of the postinjury hrQoL and the ability to work after polytrauma. Further studies on the detection of influenceable risk factors on hrQoL and ability to work in the intersectoral course of treatment should follow to enable the best possible outcome of polytrauma survivors.

[Results of the pilot phase of the Age Trauma Registry DGU®]. / Ergebnisse der Pilotphase des AltersTraumaRegister DGU®.

BACKGROUND: Since 2014, hospitals with ortho-geriatric fracture centres could be certified as AltersTraumaZentrum DGU® in Germany. To measure the quality of treatment in these centres, a geriatric trauma registry (AltersTraumaRegister DGU®) was established. OBJECTIVES: The aim of this work was to report the results of the pilot phase of the AltersTraumaRegister DGU® from the year 2015. MATERIALS AND METHODS: Included were 118 patients >70 years with hip fracture or implant-related femoral fractures. Apart from other parameters, the point of surgery, initiation of anti-osteoporotic treatment and the EQ-5D one week post-surgery was measured. RESULTS: Surgery was performed in 87% of patients within 24 h. Specific osteoporotic therapy could be increased from 4 to 63 patients. The EQ-5D was strongly restricted to one week post-surgery. CONCLUSION: Based on the timing of surgery and anti-osteoporotic therapy, the treatment seems to be successful in the ortho-geriatric fracture centres. For a better evaluation of treatment quality in the AltersTraumaZentren DGU®, implementation of follow-up examinations in the AltersTraumaRegister DGU® is essential.

The role of biological sex in severely traumatized patients on outcomes: a matched-pair analysis.

OBJECTIVE: Analyze sex differences in TraumaRegister DGU (TR-DGU). BACKGROUND: Sex differences are considered to influence trauma outcomes. However, clinical study results are controversial. METHODS: Of 29,353 prospectively recorded cases of TR-DGU, we included primary trauma room admissions with Injury Severity Score of 9 or more into the analysis. Pairs (n = 3887) were formed from 1 male and 1 female according to age, mechanism, injury severity by Abbreviated Injury Scale (for head, thorax, abdomen, extremities), and occurrence of prehospital shock. Biochemical markers, treatment modalities, length of stay, and outcome (multiple organ failure, sepsis, mortality rates) were assessed. Statistical significance was accepted at P < 0.05. Odds ratios (ORs) are given with 95% confidence interval (CI). RESULTS: Females had less multiple organ failure [OR: 1.18 (95% CI, 1.05-1.33); P = 0.007], particularly in age group of 16 to 44 years; sepsis [OR: 1.45 (95% CI, 1.21-1.74); P < 0.001]), particularly at age more than 45 years; and mortality [OR: 1.14 (95% CI, 1.01-1.28); P = 0.037]. Prehospital chest tube insertions (214 vs 158) and surgical procedures before intensive care unit admission were more often performed in males (79.7% vs 76.4%). Females had lower mean hemoglobin levels [10.7 ± 2.6 vs 11.9 ± 2.8 (mg/dL)]. There were no sex differences in fluid resuscitation, shock index, coagulation, and base excess. CONCLUSIONS: Males are more susceptible to multiple organ failure, sepsis, and mortality after trauma. Differences were not exclusively related to reproductive age and thus cannot be attributed to sex hormones alone. Females aged 16 to 44 years seem to tolerate shock better. Higher susceptibility to sepsis might be explained by male immune function or increased systemic burden from higher rates of surgical interventions.

Update of the trauma risk adjustment model of the TraumaRegister DGU™: the Revised Injury Severity Classification, version II.

INTRODUCTION: The TraumaRegister DGU™ (TR-DGU) has used the Revised Injury Severity Classification (RISC) score for outcome adjustment since 2003. In recent years, however, the observed mortality rate has fallen to about 2% below the prognosis, and it was felt that further prognostic factors, like pupil size and reaction, should be included as well. Finally, an increasing number of cases did not receive a RISC prognosis due to the missing values. Therefore, there was a need for an updated model for risk of death prediction in severely injured patients to be developed and validated using the most recent data. METHODS: The TR-DGU has been collecting data from severely injured patients since 1993. All injuries are coded according to the Abbreviated Injury Scale (AIS, version 2008). Severely injured patients from Europe (ISS ≥ 4) documented between 2010 and 2011 were selected for developing the new score (n = 30,866), and 21,918 patients from 2012 were used for validation. Age and injury codes were required, and transferred patients were excluded. Logistic regression analysis was applied with hospital mortality as the dependent variable. Results were evaluated in terms of discrimination (area under the receiver operating characteristic curve, AUC), precision (observed versus predicted mortality), and calibration (Hosmer-Lemeshow goodness-of-fit statistic). RESULTS: The mean age of the development population was 47.3 years; 71.6% were males, and the average ISS was 19.3 points. Hospital mortality rate was 11.5% in this group. The new RISC II model consists of the following predictors: worst and second-worst injury (AIS severity level), head injury, age, sex, pupil reactivity and size, pre-injury health status, blood pressure, acidosis (base deficit), coagulation, haemoglobin, and cardiopulmonary resuscitation. Missing values are included as a separate category for every variable. In the development and the validation dataset, the new RISC II outperformed the original RISC score, for example AUC in the development dataset 0.953 versus 0.939. CONCLUSIONS: The updated RISC II prognostic score has several advantages over the previous RISC model. Discrimination, precision and calibration are improved, and patients with partial missing values could now be included. Results were confirmed in a validation dataset.

Assessment of hypovolaemic shock at scene: is the PHTLS classification of hypovolaemic shock really valid?

OBJECTIVE: Validation of the classification of hypovolaemic shock suggested by the prehospital trauma life support (PHTLS) in its sixth student course manual. METHODS: Adults, entered into the TraumaRegister DGU(®) database between 2002 and 2011, were classified into reference ranges for heart rate (HR), systolic blood pressure (SBP) and Glasgow coma scale (GCS) according to the PHTLS classification of hypovolaemic shock. First, patients were grouped by a combination of all three parameters (HR, SBP and GCS) as suggested by PHTLS. Second, patients were classified by only one parameter (HR, SBP or GCS) according to PHTLS and alterations in the remaining two parameters were assessed. Furthermore, subgroup analysis for trauma mechanism and traumatic brain injury (TBI) were performed. RESULTS: Out of 46 689 patients, only 12 432 (26.5%) could be adequately classified according to PHTLS if a combination of all three criteria was assessed. In TBI patients, only 12.2% could be classified adequately, whereas trauma mechanism had no significant influence. When patients were grouped by HR, there was only a slight reduction in SBP. When grouped by SBP, GCS dropped from 14 to 8, while no significant tachycardia was observed in any group. In patients with a GCS less than 12, HR was unaltered whereas SBP was slightly reduced to 114 (±42) mm Hg. On average, GCS in TBI patients was lower within all shock groups. In penetrating trauma patients, changes in HR and SBP were more distinct, but still less than predicted by PHTLS. CONCLUSIONS: The PHTLS classification of hypovolaemic shock displays substantial deficits in adequately risk-stratifying trauma patients.

[Development and progress of the National Autopsy Network (NATON)]. / Entwicklung und Fortschritte des Nationalen Obduktionsnetzwerks (NATON).

BACKGROUND: Autopsies have long been considered the gold standard for quality assurance in medicine, yet their significance in basic research has been relatively overlooked. The COVID-19 pandemic underscored the potential of autopsies in understanding pathophysiology, therapy, and disease management. In response, the German Registry for COVID-19 Autopsies (DeRegCOVID) was established in April 2020, followed by the DEFEAT PANDEMIcs consortium (2020-2021), which evolved into the National Autopsy Network (NATON). DEREGCOVID: DeRegCOVID collected and analyzed autopsy data from COVID-19 deceased in Germany over three years, serving as the largest national multicenter autopsy study. Results identified crucial factors in severe/fatal cases, such as pulmonary vascular thromboemboli and the intricate virus-immune interplay. DeRegCOVID served as a central hub for data analysis, research inquiries, and public communication, playing a vital role in informing policy changes and responding to health authorities. NATON: Initiated by the Network University Medicine (NUM), NATON emerged as a sustainable infrastructure for autopsy-based research. NATON aims to provide a data and method platform, fostering collaboration across pathology, neuropathology, and legal medicine. Its structure supports a swift feedback loop between research, patient care, and pandemic management. CONCLUSION: DeRegCOVID has significantly contributed to understanding COVID-19 pathophysiology, leading to the establishment of NATON. The National Autopsy Registry (NAREG), as its successor, embodies a modular and adaptable approach, aiming to enhance autopsy-based research collaboration nationally and, potentially, internationally.

Trauma registry record linkage: methodological approach to benefit from complementary data using the example of the German Pelvic Injury Register and the TraumaRegister DGU(®).

BACKGROUND: In Germany, hospitals can deliver data from patients with pelvic fractures selectively or twofold to two different trauma registries, i.e. the German Pelvic Injury Register (PIR) and the TraumaRegister DGU(®) (TR). Both registers are anonymous and differ in composition and content. We describe the methodological approach of linking these registries and reidentifying twofold documented patients. The aim of the approach is to create an intersection set that benefit from complementary data of each registry, respectively. Furthermore, the concordance of data entry of some clinical variables entered in both registries was evaluated. METHODS: PIR (4,323 patients) and TR (34,134 patients) data from 2004-2009 were linked together by using a specific match code including code of the trauma department, dates of admission and discharge, patient's age, and sex. Data entry concordance was evaluated using haemoglobin and blood pressure levels at emergency department arrival, Injury Severity Score (ISS), and mortality. RESULTS: Altogether, 420 patients were identified as documented in both data sets. Linkage rates for the intersection set were 15.7% for PIR and 44.4% for TR. Initial fluid management for different Tile/OTA types of pelvic ring fractures and the patient's posttraumatic course, including intensive care unit data, were now available for the PIR population. TR is benefiting from clinical use of the Tile/OTA classification and from correlation with the distinct entity "complex pelvic injury." Data entry verification showed high concordance for the ISS and mortality, whereas initial haemoglobin and blood pressure data showed significant differences, reflecting inconsistency at the data entry level. CONCLUSIONS: Individually, the PIR and the TR reflect a valid source for documenting injured patients, although the data reflect the emphasis of the particular registry. Linking the two registries enabled new insights into care of multiple-trauma patients with pelvic fractures even when linkage rates were poor. Future considerations and development of the registries should be done in close bilateral consultation with the aim of benefiting from complementary data and improving data concordance. It is also conceivable to integrate individual modules, e.g. a pelvic fracture module, into the TR likewise a modular system in the future.

Renaissance of base deficit for the initial assessment of trauma patients: a base deficit-based classification for hypovolemic shock developed on data from 16,305 patients derived from the TraumaRegister DGU®.

INTRODUCTION: The recognition and management of hypovolemic shock still remain an important task during initial trauma assessment. Recently, we have questioned the validity of the Advanced Trauma Life Support (ATLS) classification of hypovolemic shock by demonstrating that the suggested combination of heart rate, systolic blood pressure and Glasgow Coma Scale displays substantial deficits in reflecting clinical reality. The aim of this study was to introduce and validate a new classification of hypovolemic shock based upon base deficit (BD) at emergency department (ED) arrival. METHODS: Between 2002 and 2010, 16,305 patients were retrieved from the TraumaRegister DGU® database, classified into four strata of worsening BD [class I (BD≤2 mmol/l), class II (BD>2.0 to 6.0 mmol/l), class III (BD>6.0 to 10 mmol/l) and class IV (BD>10 mmol/l)] and assessed for demographics, injury characteristics, transfusion requirements and fluid resuscitation. This new BD-based classification was validated to the current ATLS classification of hypovolemic shock. RESULTS: With worsening of BD, injury severity score (ISS) increased in a step-wise pattern from 19.1 (±11.9) in class I to 36.7 (±17.6) in class IV, while mortality increased in parallel from 7.4% to 51.5%. Decreasing hemoglobin and prothrombin ratios as well as the amount of transfusions and fluid resuscitation paralleled the increasing frequency of hypovolemic shock within the four classes. The number of blood units transfused increased from 1.5 (±5.9) in class I patients to 20.3 (±27.3) in class IV patients. Massive transfusion rates increased from 5% in class I to 52% in class IV. The new introduced BD-based classification of hypovolemic shock discriminated transfusion requirements, massive transfusion and mortality rates significantly better compared to the conventional ATLS classification of hypovolemic shock (p<0.001). CONCLUSIONS: BD may be superior to the current ATLS classification of hypovolemic shock in identifying the presence of hypovolemic shock and in risk stratifying patients in need of early blood product transfusion.

The Shock Index revisited - a fast guide to transfusion requirement? A retrospective analysis on 21,853 patients derived from the TraumaRegister DGU.

INTRODUCTION: Isolated vital signs (for example, heart rate or systolic blood pressure) have been shown unreliable in the assessment of hypovolemic shock. In contrast, the Shock Index (SI), defined by the ratio of heart rate to systolic blood pressure, has been advocated to better risk-stratify patients for increased transfusion requirements and early mortality. Recently, our group has developed a novel and clinical reliable classification of hypovolemic shock based upon four classes of worsening base deficit (BD). The objective of this study was to correlate this classification to corresponding strata of SI for the rapid assessment of trauma patients in the absence of laboratory parameters. METHODS: Between 2002 and 2011, data for 21,853 adult trauma patients were retrieved from the TraumaRegister DGU database and divided into four strata of worsening SI at emergency department arrival (group I, SI <0.6; group II, SI ≥0.6 to <1.0; group III, SI ≥1.0 to <1.4; and group IV, SI ≥1.4) and were assessed for demographics, injury characteristics, transfusion requirements, fluid resuscitation and outcomes. The four strata of worsening SI were compared with our recently suggested BD-based classification of hypovolemic shock. RESULTS: Worsening of SI was associated with increasing injury severity scores from 19.3 (± 12) in group I to 37.3 (± 16.8) in group IV, while mortality increased from 10.9% to 39.8%. Increments in SI paralleled increasing fluid resuscitation, vasopressor use and decreasing hemoglobin, platelet counts and Quick's values. The number of blood units transfused increased from 1.0 (± 4.8) in group I to 21.4 (± 26.2) in group IV patients. Of patients, 31% in group III and 57% in group IV required ≥10 blood units until ICU admission. The four strata of SI discriminated transfusion requirements and massive transfusion rates equally with our recently introduced BD-based classification of hypovolemic shock. CONCLUSION: SI upon emergency department arrival may be considered a clinical indicator of hypovolemic shock in respect to transfusion requirements, hemostatic resuscitation and mortality. The four SI groups have been shown to equal our recently suggested BD-based classification. In daily clinical practice, SI may be used to assess the presence of hypovolemic shock if point-of-care testing technology is not available.

Development and first results of a national databank on care and treatment outcome after traumatic brain injury.

PURPOSE: In absence of comprehensive data collection on traumatic brain injury (TBI), the German Society for Neurosurgery (DGNC) and the German Society for Trauma Surgery (DGU) developed a TBI databank for German-speaking countries. METHODS: From 2016 to 2020, the TBI databank DGNC/DGU was implemented as a module of the TraumaRegister (TR) DGU and tested in a 15-month pilot phase. Since its official launch in 2021, patients from the TR-DGU (intermediate or intensive care unit admission via shock room) with TBI (AIS head ≥ 1) can be enrolled. A data set of > 300 clinical, imaging, and laboratory variables, harmonized with other international TBI data collection structures is documented, and the treatment outcome is evaluated after 6- and 12 months. RESULTS: For this analysis, 318 patients in the TBI databank could be included (median age 58 years; 71% men). Falls were the most common cause of injury (55%), and antithrombotic medication was frequent (28%). Severe or moderate TBI were only present in 55% of patients, while 45% suffered a mild injury. Nevertheless, intracranial pathologies were present in 95% of brain imaging with traumatic subarachnoid hemorrhages (76%) being the most common. Intracranial surgeries were performed in 42% of cases. In-hospital mortality after TBI was 21% and surviving patients could be discharged after a median hospital stay of 11 days. At the 6-and 12 months follow-up, a favorable outcome was achieved by 70% and 90% of the participating TBI patients, respectively. Compared to a European cohort of 2138 TBI patients treated in the ICU between 2014 and 2017, patients in the TBI databank were already older, frailer, fell more commonly at home. CONCLUSION: Within five years, the TBI databank DGNC/DGU of the TR-DGU could be established and is since then prospectively enrolling TBI patients in German-speaking countries. With its large and harmonized data set and a 12-month follow-up, the TBI databank is a unique project in Europe, already allowing comparisons to other data collection structures and indicating a demographic change towards older and frailer TBI patients in Germany.

Predicting on-going hemorrhage and transfusion requirement after severe trauma: a validation of six scoring systems and algorithms on the TraumaRegister DGU.

INTRODUCTION: The early aggressive management of the acute coagulopathy of trauma may improve survival in the trauma population. However, the timely identification of lethal exsanguination remains challenging. This study validated six scoring systems and algorithms to stratify patients for the risk of massive transfusion (MT) at a very early stage after trauma on one single dataset of severely injured patients derived from the TR-DGU (TraumaRegister DGU of the German Trauma Society (DGU)) database. METHODS: Retrospective internal and external validation of six scoring systems and algorithms (four civilian and two military systems) to predict the risk of massive transfusion at a very early stage after trauma on one single dataset of severely injured patients derived from the TraumaRegister DGU database (2002-2010). Scoring systems and algorithms assessed were: TASH (Trauma-Associated Severe Hemorrhage) score, PWH (Prince of Wales Hospital/Rainer) score, Vandromme score, ABC (Assessment of Blood Consumption/Nunez) score, Schreiber score and Larsen score. Data from 56,573 patients were screened to extract one complete dataset matching all variables needed to calculate all systems assessed in this study. Scores were applied and area-under-the-receiver-operating-characteristic curves (AUCs) were calculated. From the AUC curves the cut-off with the best relation of sensitivity-to-specificity was used to recalculate sensitivity, specificity, positive predictive values (PPV), and negative predictive values (NPV). RESULTS: A total of 5,147 patients with blunt trauma (95%) was extracted from the TR-DGU. The mean age of patients was 45.7 ± 19.3 years with a mean ISS of 24.3 ± 13.2. The overall MT rate was 5.6% (n = 289). 95% (n = 4,889) patients had sustained a blunt trauma. The TASH score had the highest overall accuracy as reflected by an AUC of 0.889 followed by the PWH-Score (0.860). At the defined cut-off values for each score the highest sensitivity was observed for the Schreiber score (85.8%) but also the lowest specificity (61.7%). The TASH score at a cut-off ≥ 8.5 showed a sensitivity of 84.4% and also a high specificity (78.4%). The PWH score had a lower sensitivity (80.6%) with comparable specificity. The Larson score showed the lowest sensitivity (70.9%) at a specificity of 80.4%. CONCLUSIONS: Weighted and more sophisticated systems such as TASH and PWH scores including higher numbers of variables perform superior over simple non-weighted models. Prospective validations are needed to improve the development process and use of scoring systems in the future.

Acute management and outcome of multiple trauma patients with pelvic disruptions.

INTRODUCTION: Data on prehospital and trauma-room fluid management of multiple trauma patients with pelvic disruptions are rarely reported. Present trauma algorithms recommend early hemorrhage control and massive fluid resuscitation. By matching the German Pelvic Injury Register (PIR) with the TraumaRegister DGU (TR) for the first time, we attempt to assess the initial fluid management for different Tile/OTA types of pelvic-ring fractures. Special attention was given to the patient's posttraumatic course, particularly intensive care unit (ICU) data and patient outcome. METHODS: A specific match code was applied to identify certain patients with pelvic disruptions from both PIR and TR anonymous trauma databases, admitted between 2004 and 2009. From the resulting intersection set, a retrospective analysis was done of prehospital and trauma-room data, length of ICU stay, days of ventilation, incidence of multiple organ dysfunction syndrome (MODS), sepsis, and mortality. RESULTS: In total, 402 patients were identified. Mean ISS was 25.9 points, and the mean of patients with ISS ≥ 16 was 85.6%. The fracture distribution was as follows: 19.7% type A, 29.4% type B, 36.6% type C, and 14.3% isolated acetabular and/or sacrum fractures. The type B/C, compared with type A fractures, were related to constantly worse vital signs that necessitated a higher volume of fluid and blood administration in the prehospital and/or the trauma-room setting. This group of B/C fractures were also related to a significantly higher presence of concomitant injuries and related to increased ISS. This was related to increased ventilation and ICU stay, increased rate of MODS, sepsis, and increased rate of mortality, at least for the type C fractures. Approximately 80% of the dead had sustained type B/C fractures. CONCLUSIONS: The present study confirms the actuality of traditional trauma algorithms with initial massive fluid resuscitation in the recent therapy of multiple trauma patients with pelvic disruptions. Low-volume resuscitation seems not yet to be accepted in practice in managing this special patient entity. Mechanically unstable pelvic-ring fractures type B/C (according to the Tile/OTA classification) form a distinct entity that must be considered notably in future trauma algorithms.

Glasgow Coma Scale as a predictor for hemocoagulative disorders after blunt pediatric traumatic brain injury.

OBJECTIVE: Coagulopathy is a complication of traumatic brain injury and its presence after injury has been identified as a risk factor for prognosis. It was our aim to determine whether neurologic findings reflected by Glasgow Coma Scale at initial resuscitation can predict hemocoagulative disorders resulting from traumatic brain injury that may aggravate clinical sequelae and outcome in children. DESIGN: A retrospective analysis of 200 datasets from children with blunt, isolated traumatic brain injury documented in the Trauma Registry of the Deutsche Gesellschaft für Unfallchirurgie was conducted. Inclusion criteria were primary admission, age <14 yrs, and sustained isolated blunt traumatic brain injury. SETTING: Trauma Registry of the Deutsche Gesellschaft für Unfallchirurgie-affiliated trauma centers in Germany. PATIENTS: : Two hundred datasets of children (age <14 yrs) with blunt isolated traumatic brain injury were analyzed: children were subdivided into two groups according to Glasgow Coma Scale at the scene (Glasgow Coma Scale ≤ 8 vs. Glasgow Coma Scale >8) and reviewed for coagulation abnormalities upon emergency room admission and outcome. MEASUREMENT AND MAIN RESULTS: Fifty-one percent (n = 102 of 200) of children had Glasgow Coma Scale >8 and 49% (n = 98 of 200) had Glasgow Coma Scale ≤ 8 at the scene. The incidence of coagulopathy at admission was higher in children with Glasgow Coma Scale ≤ 8 compared to children with Glasgow Coma Scale >8: 44% (n = 31 of 71) vs. 14% (n = 11 of 79) (p < .001). Multivariate logistic regression revealed that Glasgow Coma Scale ≤ 8 at scene was associated with coagulopathy at admission (odds ratio 3.378, p = .009) and stepwise regression identified Glasgow Coma Scale ≤ 8 as an independent risk factor for coagulopathy. Mortality in children with Glasgow Coma Scale ≤ 8 at scene was substantially higher with the presence of coagulation abnormalities at admission compared to children in which coagulopathy was absent (51.6%, n = 16 of 31 vs. 5% n = 2 of 40). CONCLUSIONS: Glasgow Coma Scale ≤ 8 at scene in children with isolated traumatic brain injury is associated with increased risk for coagulopathy and mortality. These results may guide laboratory testing, management, and blood bank resources in acute pediatric trauma care.

Predictive Models and Algorithms for the Need of Transfusion Including Massive Transfusion in Severely Injured Patients.

BACKGROUND: Despite improvements on how to resuscitate exsanguinating patients, one remaining key to improve outcome is to expeditiously and reproducibly identify patients most likely to require transfusion including massive transfusion (MT). This work summarizes yet developed algorithms/scoring systems for transfusion including MT in civilian and military trauma populations. METHODS: A systematic search of evidence was conducted utilizing OVID/MEDLINE (1966 to present) and the 'Medical Algorithms Project'. RESULTS AND CONCLUSIONS: The models developed suggest combinations of physiologic, hemodynamic, laboratory, injury severity and demographic triggers identified on the initial evaluation of the bleeding trauma patient. Many approaches use a combination of dichotomous variables readily accessible after arrival but others rely on time-consuming calculations or complex algorithms and may have limited real-time application. Weighted and more sophisticated systems including higher numbers of variables perform superior. A common limitation to all models is their retrospective nature, and prospective validations are urgently needed. Point-of-care viscoelastic testing may be an alternative to these systems.

FIBTEM provides early prediction of massive transfusion in trauma.

INTRODUCTION: Prediction of massive transfusion (MT) among trauma patients is difficult in the early phase of trauma management. Whole-blood thromboelastometry (ROTEM®) tests provide immediate information about the coagulation status of acute bleeding trauma patients. We investigated their value for early prediction of MT. METHODS: This retrospective study included patients admitted to the AUVA Trauma Centre, Salzburg, Austria, with an injury severity score ≥16, from whom blood samples were taken immediately upon admission to the emergency room (ER). ROTEM® analyses (extrinsically-activated test with tissue factor (EXTEM), intrinsically-activated test using ellagic acid (INTEM) and fibrin-based extrinsically activated test with tissue factor and the platelet inhibitor cytochalasin D (FIBTEM) tests) were performed. We divided patients into two groups: massive transfusion (MT, those who received ≥10 units red blood cell concentrate within 24 hours of admission) and non-MT (those who received 0 to 9 units). RESULTS: Of 323 patients included in this study (78.9% male; median age 44 years), 78 were included in the MT group and 245 in the non-MT group. The median injury severity score upon admission to the ER was significantly higher in the MT group than in the non-MT group (42 vs 27, P < 0.0001). EXTEM and INTEM clotting time and clot formation time were significantly prolonged and maximum clot firmness (MCF) was significantly lower in the MT group versus the non-MT group (P < 0.0001 for all comparisons). Of patients admitted with FIBTEM MCF 0 to 3 mm, 85% received MT. The best predictive values for MT were provided by hemoglobin and Quick value (area under receiver operating curve: 0.87 for both parameters). Similarly high predictive values were observed for FIBTEM MCF (0.84) and FIBTEM A10 (clot amplitude at 10 minutes; 0.83). CONCLUSIONS: FIBTEM A10 and FIBTEM MCF provided similar predictive values for massive transfusion in trauma patients to the most predictive laboratory parameters. Prospective studies are needed to confirm these findings.

Transfusion in trauma: thromboelastometry-guided coagulation factor concentrate-based therapy versus standard fresh frozen plasma-based therapy.

INTRODUCTION: Thromboelastometry (TEM)-guided haemostatic therapy with fibrinogen concentrate and prothrombin complex concentrate (PCC) in trauma patients may reduce the need for transfusion of red blood cells (RBC) or platelet concentrate, compared with fresh frozen plasma (FFP)-based haemostatic therapy. METHODS: This retrospective analysis compared patients from the Salzburg Trauma Centre (Salzburg, Austria) treated with fibrinogen concentrate and/or PCC, but no FFP (fibrinogen-PCC group, n = 80), and patients from the TraumaRegister DGU receiving ≥ 2 units of FFP, but no fibrinogen concentrate/PCC (FFP group, n = 601). Inclusion criteria were: age 18-70 years, base deficit at admission ≥ 2 mmol/L, injury severity score (ISS) ≥ 16, abbreviated injury scale for thorax and/or abdomen and/or extremity ≥ 3, and for head/neck < 5. RESULTS: For haemostatic therapy in the emergency room and during surgery, the FFP group (ISS 35.5 ± 10.5) received a median of 6 units of FFP (range: 2, 51), while the fibrinogen-PCC group (ISS 35.2 ± 12.5) received medians of 6 g of fibrinogen concentrate (range: 0, 15) and 1200 U of PCC (range: 0, 6600). RBC transfusion was avoided in 29% of patients in the fibrinogen-PCC group compared with only 3% in the FFP group (P< 0.001). Transfusion of platelet concentrate was avoided in 91% of patients in the fibrinogen-PCC group, compared with 56% in the FFP group (P< 0.001). Mortality was comparable between groups: 7.5% in the fibrinogen-PCC group and 10.0% in the FFP group (P = 0.69). CONCLUSIONS: TEM-guided haemostatic therapy with fibrinogen concentrate and PCC reduced the exposure of trauma patients to allogeneic blood products.

Balanced massive transfusion ratios in multiple injury patients with traumatic brain injury.

INTRODUCTION: Retrospective studies have demonstrated a potential survival benefit from transfusion strategies using an early and more balanced ratio between fresh frozen plasma (FFP) concentration and packed red blood cell (pRBC) transfusions in patients with acute traumatic coagulopathy requiring massive transfusions. These results have mostly been derived from non-head-injured patients. The aim of the present study was to analyze whether a regime using a high FFP:pRBC transfusion ratio (FFP:pRBC ratio >1:2) would be associated with a similar survival benefit in severely injured patients with traumatic brain injury (TBI) (Abbreviated Injury Scale (AIS) score, head ≥ 3) as demonstrated for patients without TBI requiring massive transfusion (≥ 10 U of pRBCs). METHODS: A retrospective analysis of severely injured patients from the Trauma Registry of the Deutsche Gesellschaft für Unfallchirurgie (TR-DGU) was conducted. Inclusion criteria were primary admission, age ≥ 16 years, severe injury (Injury Severity Score (ISS) ≥ 16) and massive transfusion (≥ 10 U of pRBCs) from emergency room to intensive care unit (ICU). Patients were subdivided into patients with TBI (AIS score, head ≥ 3) and patients without TBI (AIS score, head <3), as well as according to the transfusion ratio they had received: high FFP:pRBC ratio (FFP:pRBC ratio >1:2) and low FFP:pRBC ratio (FFP:pRBC ratio ≤1:2). In addition, morbidity and mortality between the two groups were compared. RESULTS: A total of 1,250 data sets of severely injured patients from the TR-DGU between 2002 and 2008 were analyzed. The mean patient age was 42 years, the majority of patients were male (72.3%), the mean ISS was 41.7 points (±15.4 SD) and the principal mechanism of injury was blunt force trauma (90%). Mortality was statistically lower in the high FFP:pRBC ratio groups versus the low FFP:pRBC ratio groups, regardless of the presence or absence of TBI and across all time points studied (P < 0.001). The frequency of sepsis and multiple organ failure did not differ among groups, except for sepsis in patients with TBI who received a high FFP:pRBC ratio transfusion. Other secondary end points such as ventilator-free days, length of stay in the ICU and overall in-hospital length of stay differed significantly between the two study groups, but not when only data for survivors were analyzed. CONCLUSIONS: These results add more detailed knowledge to the concept of a high FFP:pRBC ratio during early aggressive resuscitation, including massive transfusion, to decrease mortality in severely injured patients both with and without accompanying TBI. Future research should be conducted with a larger number of patients to prove these results in a prospective study.

Goal-directed coagulation management of major trauma patients using thromboelastometry (ROTEM)-guided administration of fibrinogen concentrate and prothrombin complex concentrate.

INTRODUCTION: The appropriate strategy for trauma-induced coagulopathy management is under debate. We report the treatment of major trauma using mainly coagulation factor concentrates. METHODS: This retrospective analysis included trauma patients who received >or= 5 units of red blood cell concentrate within 24 hours. Coagulation management was guided by thromboelastometry (ROTEM). Fibrinogen concentrate was given as first-line haemostatic therapy when maximum clot firmness (MCF) measured by FibTEM (fibrin-based test) was <10 mm. Prothrombin complex concentrate (PCC) was given in case of recent coumarin intake or clotting time measured by extrinsic activation test (EXTEM) >1.5 times normal. Lack of improvement in EXTEM MCF after fibrinogen concentrate administration was an indication for platelet concentrate. The observed mortality was compared with the mortality predicted by the trauma injury severity score (TRISS) and by the revised injury severity classification (RISC) score. RESULTS: Of 131 patients included, 128 received fibrinogen concentrate as first-line therapy, 98 additionally received PCC, while 3 patients with recent coumarin intake received only PCC. Twelve patients received FFP and 29 received platelet concentrate. The observed mortality was 24.4%, lower than the TRISS mortality of 33.7% (P = 0.032) and the RISC mortality of 28.7% (P > 0.05). After excluding 17 patients with traumatic brain injury, the difference in mortality was 14% observed versus 27.8% predicted by TRISS (P = 0.0018) and 24.3% predicted by RISC (P = 0.014). CONCLUSIONS: ROTEM-guided haemostatic therapy, with fibrinogen concentrate as first-line haemostatic therapy and additional PCC, was goal-directed and fast. A favourable survival rate was observed. Prospective, randomized trials to investigate this therapeutic alternative further appear warranted.

A nationwide fluidics biobank of polytraumatized patients: implemented by the Network "Trauma Research" (NTF) as an expansion to the TraumaRegister DGU® of the German Trauma Society (DGU).

To decrypt the complexity of the posttraumatic immune responses and to potentially identify novel research pathways for exploration, large-scale multi-center projects including not only in vivo and in vitro modeling, but also temporal sample and material collection along with clinical data capture from multiply injured patients is of utmost importance. To meet this gap, a nationwide biobank for fluidic samples from polytraumatized patients was initiated in 2013 by the task force Network "Trauma Research" (Netzwerk Traumaforschung, NTF) of the German Trauma Society (Deutsche Gesellschaft für Unfallchirurgie e.V., DGU). The NTF-Biobank completes the clinical NTF-Biobank Database and complements the TR-DGU with temporal biological samples from multiply injured patients. The concept behind the idea of the NTF-Biobank was to create a robust interface for meaningful innovative basic, translational and clinical research. For the first time, an integrated platform to prospectively evaluate and monitor candidate biomarkers and/or potential therapeutic targets in biological specimens of quality-controlled and documented patients is introduced, allowing reduction in variability of measurements with high impact due to its large sample size. Thus, the project was introduced to systemically evaluate and monitor multiply injured patients for their (patho-)physiological sequalae together with their clinical treatment strategies applied for overall outcome improval.

Trauma-induced coagulopathy upon emergency room arrival: still a significant problem despite increased awareness and management?

PURPOSE: Over the last decade, the pivotal role of trauma-induced coagulopathy has been described and principal drivers have been identified. We hypothesized that the increased knowledge on coagulopathy of trauma would translate into a more cautious treatment, and therefore, into a reduced overall incidence rate of coagulopathy upon ER admission. PATIENTS AND METHODS: Between 2002 and 2013, 61,212 trauma patients derived from the TraumaRegister DGU® had a full record of coagulation parameters and were assessed for the presence of coagulopathy. Coagulopathy was defined by a Quick's value < 70% and/or platelet counts < 100,000/µl upon ER admission. For each year, the incidence of coagulopathy, the amount of pre-hospital administered i.v.-fluids and transfusion requirements were assessed. RESULTS: Coagulopathy upon ER admission was present in 24.5% of all trauma patients. Within the years 2002-2013, the annual incidence of coagulopathy decreased from 35 to 20%. Even in most severely injured patients (ISS > 50), the incidence of coagulopathy was reduced by 7%. Regardless of the injury severity, the amount of pre-hospital i.v.-fluids declined during the observed period by 51%. Simultaneously, morbidity and mortality of severely injured patients were on the decrease. CONCLUSION: During the 12 years observed, a substantial decline of coagulopathy has been observed. This was paralleled by a significant decrease of i.v.-fluids administered in the pre-hospital treatment. The reduced presence of coagulopathy translated into decreased transfusion requirements and mortality. Nevertheless, especially in the most severely injured patients, posttraumatic coagulopathy remains a frequent and life-threatening syndrome.