This study involved propensity score matching analysis of a selection of patients from the database of a multicenter, retrospective observational study of 42 ICUs throughout Japan. We identified that administration of rhTM was related to a reduced mortality in sepsis patients with severe respiratory failure, regardless of the complication of DIC. VFDs trended to be higher in the matched rhTM group than the matched no rhTM group. In addition, bleeding complications were not increased by the administration of rhTM.
Our study had some limitations. First, we could not identify the exact timing of therapeutic interventions. However, therapeutic interventions, including the administration of rhTM, usually occurred at the time of ICU admission, and other therapeutic interventions were not affected by rhTM administration. Therefore, we considered it acceptable to use the therapeutic interventions to estimate the propensity score. Second, the dose and duration of therapeutic interventions, including rhTM, could not be identified. However, we assumed that patients received the dose and duration approved in Japan. Third, we evaluated the severity of respiratory failure using the respiratory SOFA score. More detailed information (e.g., ventilator settings, lung injury scores) may be needed for an accurate evaluation. Finally, we could not follow up patients after discharge from the treating hospital.
Using propensity analysis in a large cohort, we identified that administration of rhTM was related to a reduced mortality in sepsis patients with severe respiratory failure, regardless of the complication of DIC. To understand the clinical implications of this, future studies of patients with severe respiratory failure, such as septic ARDS, in prospective multicenter randomized trials should be conducted.
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