J Trauma
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Randomized Controlled Trial Multicenter Study Comparative Study
Recombinant activated factor VII safety in trauma patients: results from the CONTROL trial.
Safety data on recombinant activated factor VII (rFVIIa, NovoSeven; Novo Nordisk A/S, Bagsværd, Denmark) in actively hemorrhaging trauma patients are limited. We present detailed safety data from a large multicenter, randomized, placebo-controlled phase III study (the CONTROL trial). ⋯ This represents the largest placebo-controlled dataset of rFVIIa use in trauma patients to date. In this prospective study of critically bleeding trauma patients, rFVIIa use was associated with an imbalance of investigator-reported Acute myocardial infarction/non-ST segment elevation myocardial infarction (AMI/NSTEMI), but was not associated with an increased risk for other AEs, including TE complications.
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Tranexamic acid (TXA) is an antifibrinolytic that inhibits both plasminogen activation and plasmin activity, thus preventing clot break-down rather than promoting new clot formation. TXA has been used around the world to safely control bleeding since the 1960s. A large randomized trial recently conducted in >20,000 trauma patients adds to the large body of data documenting the usefulness of TXA in promoting hemostasis. ⋯ This inexpensive and safe drug should be incorporated into trauma clinical practice guidelines and treatment protocols. Further research on possible alternate mechanisms of action and dosing regimens for TXA should be undertaken. Concurrent to these endeavors, TXA should be adopted for use in bleeding trauma patients because it is the only drug with prospective clinical evidence to support this application.
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Moped and scooter crash outcomes in the United States were last reported more than 20 years ago. These vehicles have experienced resurgence in popularity with sales that have increased up to 60% in recent years. The purpose of this study is to identify risk factors between severe and nonsevere driver-related injuries and to identify modifiable risk factors. ⋯ These results suggest that most of the traffic infrastructure does not accommodate the safety of moped and scooter drivers. Focused interventions and further investigation into statewide traffic rules may improve moped crash outcomes.