Impact of a prehospital discrimination between trauma patients with or without early acute coagulopathy of trauma and the need for damage control resuscitation: rationale and design of a multicenter randomized phase II trial.

BACKGROUND: The evidence of the Trauma Induced Coagulopathy Clinical Score (TICCS) accuracy has been evaluated in several studies but the potential effect of its use on patient outcomes needs to be evaluated. The primary objective of this study is to evaluate the impact on mortality of a prehospital discrimination between trauma patients with or without a potential need for damage control resuscitation. METHODS: The trial will be designed as randomized phase II clinical trial with comparison of the experimental protocol against the standard of care. The TICCS will be calculated on the site of injury for the patients of the intervention group and treatment will be guided by the TICCS value. Seven days mortality, 30 days mortality, global use of blood products and global hospital length-of-stay will be compared. DISCUSSION: Many data suggest that a very early flagging of trauma patients in need for DCR would be beneficial but this need to be proved. Do we improve our quality of care by an earlier diagnosis? Does a prehospital discrimination between trauma patients with or without a potential need for DCR has a positive impact?

Thromboelastometry in trauma care: a place in the 2018 Belgian health care system?

Introduction Evidence supporting the use of Thromboelastography (TEG®) and rotational thromboelastometric (ROTEM®) in the trauma setting remains limited. We present the results of a practical evaluation of the potential interest of ROTEM® in the diagnosis of acute coagulopathy and the need for emergent blood product transfusion in the general trauma population of a non-trauma Belgian emergency department. Methods Extracting a convenience cohort from the initial prospective TICCS study, we performed a retrospective analysis to test the following hypothesis: ROTEM® might be helpful to discriminate trauma patients with or without acute coagulopathy. Fifty patients were included and ROTEM® results were compared to conventional coagulation tests results, blood transfusion need and outcome. Results With a negative predictive value of 97.6% and a positive predictive value of 42.9%, a strictly normal ROTEM® profile at the time of admission seems to be able to exclude the presence of acute coagulopathy. ROTEM® also seems to be accurate in identifying patients without the need for emergent blood product transfusions. Conclusion In a population of trauma patients of a Belgian general emergency department, a strictly normal coagulation profile evaluated by ROTEM® at hospital entry is associated with a normal coagulation profile evaluated by INR and fibrinogen levels and the absence of any indication of blood product transfusion. ROTEM® may be useful for preselection of trauma patients at risk for coagulopathy within the global trauma population. This, however, would need confirmation in further investigations. TRIAL REGISTRATION: clinicaltrials.gov NCT02132208 Registered 6 May 2014.

Prehospital identification of trauma patients with early acute coagulopathy and massive bleeding: results of a prospective non-interventional clinical trial evaluating the Trauma Induced Coagulopathy Clinical Score (TICCS).

INTRODUCTION: Identifying patients who need damage control resuscitation (DCR) early after trauma is pivotal for adequate management of their critical condition. Several trauma-scoring systems have been developed to identify such patients, but most of them are not simple enough to be used in prehospital settings in the early post-traumatic phase. The Trauma Induced Coagulopathy Clinical Score (TICCS) is an easy-to-measure and strictly clinical trauma score developed to meet this medical need. METHODS: TICCS is a 3-item clinical score (range: 0 to 18) based on the assessment of general severity, blood pressure and extent of body injury and calculated by paramedics on-site for patients with severe trauma. This non-interventional prospective study was designed to assess the ability of TICCS to discern patients who need DCR. These patients were patients with early acute coagulopathy of trauma (EACT), haemorrhagic shock, massive transfusion and surgical or endovascular haemostasis during hospitalization. Diagnosis of EACT was assessed by both thromboelastometry and conventional coagulation tests. RESULTS: During an 18-month period, 89 severe trauma patients admitted to the general emergency unit at our hospital were enrolled in the study, but 7 were excluded for protocol violations. Of the 82 remaining patients, 8 needed DCR and 74 did not. With receiver operating characteristic curve analysis, TICCS proved to be a powerful discriminant test (area under the curve = 0.98; 95% CI: 0.92 to 1.0). A cutoff of 10 on the TICCS scale provided the best balance between sensitivity (100%; 95% CI: 53.9 to 100) and specificity (95.9%; 95% CI: 88.2 to 99.2). The positive predictive value was 72.7%, and the negative predictive value was 100.0%. CONCLUSION: TICCS can be easily and rapidly measured by paramedics at the trauma site. In this study of blunt trauma patients, TICCS was able to discriminate between patients with and without need for DCR. TICCS on-site evaluation should allow initiation of optimal care immediately upon hospital admission of patients with severe trauma in need of DCR. However, a larger multicentre prospective study is needed for in-depth validation of TICCS. TRIAL REGISTRATION: Clinicaltrials.gov ID: NCT02132208 (registered 6 May 2014).