A Multicenter, Randomized Controlled Trial of Immediate Total-Body CT Scanning in Trauma Patients (REACT-2)

Joanne C Sierink; Teun Peter Saltzherr; Ludo FM Beenen; Jan SK Luitse; Markus W Hollmann; Johannes B Reitsma; Michael JR Edwards; Joachim Hohmann; Benn JA Beuker; Peter Patka; James W Suliburk; Marcel G W Dijkgraaf; J Carel Goslings

Disclosures

BMC Emerg Med. 2012;12(4) 

In This Article

Discussion

The need for prospective studies to measure the effect of immediate total-body CT scanning in trauma care has been stressed recently by several authors.[8,22,23,25,29] Retrospective studies have shown the possible benefits in time and outcome of immediate total-body CT scanning in trauma patients. The next step is to compare its usage to the current best imaging strategy according to ATLS guidelines in a prospective trial.

The primary question that needs to be answered is whether immediate total-body CT scanning in severely injured trauma patients decreases mortality and significant morbidity when compared to conventional imaging strategies supplemented with CT. Therefore, randomization is within the hospital, ensuring that a comparison between imaging protocols is made per hospital instead of between hospitals. The design of the trial is multi-centered, with participating centers in The Netherlands, Switzerland and North America. This design assures that differences in trauma populations, trauma mechanisms and workflow in different parts of the world are taken into account as well. This is important to make sure that if an effect on outcome is seen that this can solely be attributed to the usage of a total-body CT scan.

The in- and exclusion criteria assure that only potentially severely injured trauma patients are included and over triage is minimized. Especially severely injured patients are thought to benefit the most from fast and detailed information that becomes available with total-body CT scanning. Selecting the right patients for immediate total-body CT scanning is therefore crucial. Since the excluded trauma patients will be registered as well, final analysis will show whether the chosen inclusion criteria led to an appropriate selection of patients. Furthermore, severely injured patients are those patients in whom the radiation dose may be justifiable since their possible life-threatening injuries require accurate treatment as fast as possible. Trauma patients are exposed to a great amount of radiation and it is well known that CT scanning is a significant contributor to iatrogenic radiation exposure.[31] The mean effective dose received by trauma patients evaluated by conventional imaging protocols supplemented with CT scanning was found to be 22.7 milliSievert (mSv).[32] A single total-body CT scan accounts for 14–21 milliGray (mGy), which in medical X-ray studies is equal to mSv.[31] However, cumulative doses for all the radiological examinations undertaken during hospitalization may be much higher.[33] The long-term effects of the radiation exposure are based upon estimations, but the most concerning is an increased cancer risk. For a single total-body CT examination the estimated lifetime attributable cancer mortality risk is thought to be around 0.08%.[31]

After conventional imaging in terms of X-rays and ultrasound has been finished the trauma leader has to decide whether or not selective CT should take place. The ATLS guidelines provide some decision rules but to some extent it is susceptible to individual judgment. Experience of the trauma leader and local infrastructures may influence these decisions. Furthermore, the randomization between total-body CT and conventional imaging supplemented with CT within each center holds the risk of a learning curve experienced by trauma leaders. If the trauma leader suspects detecting more injuries with a total-body CT scan than was expected on clinical grounds, performing selective CT scanning in the conventional arm could become more easily accessible and may lower the possible differences in outcome between the study groups. That is why the indication for selective CT scanning in the conventional arm are pre-defined, based on combined local protocols of the participating centers. The standardization of the conventional arm will lower the aforementioned risks.

This trial aims to determine the optimal diagnostic strategy for severely injured trauma patients in the ED. If immediate total-body CT scanning is found to be the best imaging strategy in severely injured trauma patients it could replace conventional imaging supplemented with CT in this specific group. This will probably minimize the total diagnostic work-up time of the initial trauma evaluation. How this reflects in outcome needs to be analyzed in this trial. Furthermore, severely injured patients are already likely to receive selective CT scanning after conventional imaging according to ATLS guidelines or according to local trauma protocols. Segmented CT scanning in these patients, added to the conventional work-up, will result in a high total radiation dose because of overlapping radiation fields. It could therefore even be possible that an immediate total-body CT results in a lower the total effective radiation dose compared to the conventional work-up with selective CT scanning.[27]

The trial not only focuses on clinical outcome in terms of mortality and morbidity. Since radiation exposure and cost-effectiveness will be taken into account as well, the REACT-2 trial will provide a detailed overview of considerations that should be taken into account when discussing the efficacy of immediate total-body CT scanning in trauma patients. The large sample size will make sure that results are reliable and can be generalized to all international trauma populations and centers.

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