1. Evaluation of the capacity of the trauma induced coagulopathy clinical score (ticcs) TO identify trauma patients presenting early acute coagulopathy evaluated by thromboelastography. Tonglet M, Minon JM, Vergnion M, CHR de la Citadelle, LIEGE, BELGIUM
DISCUSSION
Our interim results suggest that the TICCS could be an efficient tool for identifying trauma patients suffering from active bleeding associated with trauma induced coagulopathy and in need for DCR.
By using the TICCS in the pre-hospital setting and “flagging” patients at that moment, specific resources can be mobilised, allowing general emergency units to offer a high quality DCR at patient’s arrival: human resources would be waiting in the shock room, the massive transfusion protocol would have been activated in due time allowing thawing the necessary AB Fresh Frozen Plasma units and preparing the O Packed Red Blood Cells units before patient’s arrival, the operation theatre would have been alerted and ready to intervene as well as radiologist for radiological studies as needed.
LATE BREAKING NEWS
The study has now just been completed. 89 patients have been enrolled; 2 patients had to be excluded because of age under 12 , 5 because of lack of data. So, 82 patients are evaluable. Very initial statistical analysis confirms the interim analysis made on 47 patients (see Table 2 below).
INTRODUCTION
Initiating Damage Control Resuscitation (DCR) as early as possible in severe trauma patients with Early Acute Coagulopathy of Trauma (EACT) is pivotal for patients’ survival. DCR that combines damage control surgery, permissive hypotension and early aggressive haemostatic resuscitation (EAHR), however implies among other things surgical and transfusion resources that are available 24H/7d in trauma centres but cannot be offered, for economic reasons, in emergency units from general hospitals.
In Belgium, in the absence of trauma centres, trauma patients are referred to general hospitals. 50 trauma patients per year are so referred to our emergency unit “diluted” in more than 65,000 non-trauma cases. This “dilution” prohibits maintaining the necessary organisation for immediate initiation of DCR preventing trauma patients with EACT to be optimally managed.
In order to allow DCR (and EAHR) in severe trauma patients with EACT at hospital entry, we have developed an easy-to-measure purely clinical score (the TICCS) aiming at “flagging” patients with EACT on the site of injury. In contrast to currently available trauma scoring systems, our score can be calculated by paramedics in less than 1 min and then communicated to the hospital allowing taking the necessary organisational measures before patient’s arrival. “Flagging” trauma patients with EACT on the site of injury and activating then the necessary resources for an immediate DCR at patient’s hospital entry could allow saving around 45  minutes in the initiation of DCR compared to the current trauma patients’ management in our emergency unit.
A prospective single-centre non-comparative non-interventional open study has been designed to validate, in approximately 100 trauma patients, the correlation between TICCS evaluated on the site of injury and thromboelastometry using TEG-ROTEM® made on a whole blood sample taken at the latest 30 min after patient’s arrival in the resuscitation room.
MATERIAL AND METHODS
This prospective single-centre non-interventional non-controlled open clinical trial has been submitted to and approved by the Ethics Committee of our hospital before study initiation. It has been started in January 2012 and is still on-going. The main objective of the study is to evaluate the correlation between the result of TICCS and the presence of haemorrhagic shock and coagulopathy. The presence of coagulopathy is to be assessed by thromboelastometry using TEG-ROTEM® measured at the latest 30 minutes after patient’s hospital entry or, if not available, by conventional coagulation tests (Fibrinogen, INR, platelets). Coagulopathy demonstrated by TEG-ROTEM® has been defined as the presence of a significant abnormality (more than 20%) at least for one of the following values: CT, CFT, MCF and ML for EXTEM and MCF for FibTEM.
Haemorrhagic shock is to be assessed by the treating physician at hospital entry on the basis of persistent hypotension due to a demonstrated active bleeding. All patients admitted to our shock room and aged more than 12 are eligible. In complement to TICCS, ISS, ABC score and TASH score are to be measured in the emergency unit. Surgical and transfusion needs are to be recorded all along patients’ hospitalization. PH, base excess and calcemia are to be recorded at patients’ admission.
THE TICCS
The TICCS ranges from 0 to18. It is a 3-item based score considering (I) the severity of trauma (for 2 points), (II) its hemodynamic repercussions (for 5 points) and (III) the extent of the body injury (for 11 points).
- 2 points are attributed if the patient is judged critical. If he isn’t, no point is attributed.
- The patient gets 5 points if his pre-hospital systolic blood pressure is below 90 mmHg. 0 if SBP is always above 90 mmHg.
- 11 points are attributed for the extent of body injury, distributed like this: 1 point for head and neck, 1 point for each extremity, 2 points for the torso region, 2 points for abdominal region and 2 points for the pelvic region.
INTERIM RESULTS
Between January 2012 and December 2012, 47 patients have been entered into the study and are so included in this interim analysis.
For the analysis, two groups of patients were generated based on results of TICCS using a cut-off value of 10 chosen after evaluation of the results of the first 20 patients entered into the study.
All patients with TICCS >=10 had a hypocoagulable status both in EXTEM and FibTEM. In contrast, only 2.7% of the patients with TICCS<10 had abnormalities on EXTEM and 16.2% on FibTEM. Conventional coagulation laboratory tests show the same tendency.
83% of the patients with TICCS>=10 were diagnosed with hemorrhagic shock. 60% of them required urgent surgical haemostasis and massive transfusion (defined by the use of more than 10 units of RBC within the firsts 24 hours), the other 40% died before they could benefit from it.
Only one patient out of 41 with TICCS<10 was diagnosed with hemorrhagic shock. He needed urgent surgical haemostasis and transfusion of a small amount of blood products.
These interim results are summarized in table 1 below.
Table 2. Sensibility, specificity, PPV and NPV of the TICCS to identify patients with the association of all the followings: coagulopathy on TEG-ROTEM, hemorrhagic shock, need for urgent surgical haemostasis and massive transfusion from the ones without any of those. Results from the definitive study (82 patients).
Comparison of TICCS with ABC, TASH and ISS indicates that TICCS>=10 has a similar PPV for identifying patients associating acute coagulopathy, diagnosis of hemorrhagic shock, need for urgent surgical procedure and massive transfusion than ABC>=2, TASH>=16 and ISS>=25. (Data not shown here)
TICCS < 10
TICCS >= 10
NO NEED FOR DCR
RED FLAG
ACTIVE BLEEDING + ACUTE COAGULOPATHY
NEED FOR DCR
Table1: Summary of Interim Results
CONCLUSION
Early pre-hospital “flagging” of trauma patients with active bleeding and EACT could allow general emergency units preparing the specific resources needed to offer high quality DCR at patient’s arrival at the emergency unit for the limited number patients needing it (impact on cost-effectiveness of patient’s support) and would shorten the time between injury and DCR initiation (impact on patients’ survival).
The TICCS is a easy-to-measure purely clinical score that seems to be a predictive tool, able to discriminate trauma patients with active bleeding, EACT and in need for DCR from those without this aggravating combination.
Consequently, based on the result of the final statistical analysis on a total of 82 patients, it could then be decided to further increase the number of patients to be included and to recruit additional study centres or, more probably, to evaluate, in a new non-interventional clinical study to be initiated, the impact of introducing the TICCS in our trauma patients’ management guidelines on patients’ survival and on cost-effectiveness of this trauma patients’ management strategy.
BODY INJURIES ? 11 POINTS
CRITICAL ? YES: 2 POINTS
NO: 0 POINT
SBP < 90 MMHG: 5 POINTS
> 90 MMHG: 0 POINT 1 2
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