The Restrictive Red Blood Cell Transfusion Strategy for Critically Injured Patients (RESTRIC) trial: a cluster-randomized, crossover, non-inferiority multicenter trial of restrictive transfusion in trauma.

BACKGROUND: The efficacies of fresh frozen plasma and coagulation factor transfusion have been widely evaluated in trauma-induced coagulopathy management during the acute post-injury phase. However, the efficacy of red blood cell transfusion has not been adequately investigated in patients with severe trauma, and the optimal hemoglobin target level during the acute post-injury and resuscitation phases remains unclear. Therefore, this study aimed to examine whether a restrictive transfusion strategy was clinically non-inferior to a liberal transfusion strategy during the acute post-injury phase. METHODS: This cluster-randomized, crossover, non-inferiority multicenter trial was conducted at 22 tertiary emergency medical institutions in Japan and included adult patients with severe trauma at risk of major bleeding. The institutions were allocated a restrictive or liberal transfusion strategy (target hemoglobin levels: 7-9 or 10-12 g/dL, respectively). The strategies were applied to patients immediately after arrival at the emergency department. The primary outcome was 28-day survival after arrival at the emergency department. Secondary outcomes included transfusion volume, complication rates, and event-free days. The non-inferiority margin was set at 3%. RESULTS: The 28-day survival rates of patients in the restrictive (n = 216) and liberal (n = 195) strategy groups were 92.1% and 91.3%, respectively. The adjusted odds ratio for 28-day survival in the restrictive versus liberal strategy group was 1.02 (95% confidence interval: 0.49-2.13). Significant non-inferiority was not observed. Transfusion volumes and hemoglobin levels were lower in the restrictive strategy group than in the liberal strategy group. No between-group differences were noted in complication rates or event-free days. CONCLUSIONS: Although non-inferiority of the restrictive versus liberal transfusion strategy for 28-day survival was not statistically significant, the mortality and complication rates were similar between the groups. The restrictive transfusion strategy results in a lower transfusion volume. TRIAL REGISTRATION NUMBER: umin.ac.jp/ctr: UMIN000034405, registration date: 8 October 2018.

Impact of increased calls to rapid response systems on unplanned ICU admission.

BACKGROUND: Whether hospital bed number and rapid response system (RRS) call rate is associated with the clinical outcomes of patients who have RRS activations is unknown. We test a hypothesis that hospital volume and RRS call rates are associated with the clinical outcomes of patients with RRSs. METHODS: This is a retrospective chart analysis of an existing dataset associated with In-Hospital Emergency Registry in Japan. In the present study, 4818 patients in 24 hospitals from April 2014 to March 2018 were analyzed. Primary outcome variable was an unplanned intensive care unit (ICU) admission after RRS activation. RESULTS: In the primary analysis of the study using a multivariate analysis adjusting potential confounding factors, higher RRS call rate was significantly associated with decreased unplanned ICU admissions (P < 0.0001, Odds ratio [OR] 0.95, 95% confidence interval [CI] 0.92-0.98), but there was no significant association of hospital volume with unplanned ICU admissions (P = 0.44). In the secondary analysis of the study, there was a non-significant trend of increased cardiac arrest on arrival at the location of the RRS provider at large-volume hospitals (P = 0.084, OR 1.16, 95% CI 0.98-1.38). Large-volume hospitals had a significantly higher 1-month mortality rate (P = 0.0040, OR 1.10, 95% CI 1.03-1.18). CONCLUSION: Hospitals with increased RRS call rates had significantly decreased unplanned ICU admission in patients who had RRS activations. Patients who had RRS activations at large-volume hospitals had an increased 1-month mortality rate.

Timing and Location of Medical Emergency Team Activation Is Associated with Seriousness of Outcome: An Observational Study in a Tertiary Care Hospital.

PURPOSE: The medical emergency team (MET) can be activated anytime and anywhere in a hospital. We hypothesized the timing and location of MET activation are associated with seriousness of outcome. MATERIALS AND METHODS: We tested for an association of clinical outcomes with timing and location using a university hospital cohort in Japan (n = 328). The primary outcome was short-term serious outcome (unplanned ICU admission after MET activation or death at scene). RESULTS: Patients for whom the MET was activated in the evening or night-time had significantly higher rates of short-term serious outcome than those for whom it was activated during the daytime (vs. evening: adjusted OR = 2. 53, 95% CI = 1.24-5.13, P = 0.010; night-time: adjusted OR = 2.45, 95% CI = 1.09-5.50, P = 0.030). Patients for whom the MET was activated in public space had decreased short-term serious outcome compared to medical spaces (public space: adjusted OR = 0.19, 95% CI = 0.07-0.54, P = 0.0017). Night-time (vs. daytime) and medical space (vs. public space) were significantly associated with higher risks of unexpected cardiac arrest and 28-day mortality. CONCLUSIONS: Patients for whom the MET was activated in the evening/night-time, or in medical space, had a higher rate of short-term serious outcomes. Taking measures against these risk factors may improve MET performance.

Empiric Antibiotic Therapy for Severe Sepsis and Septic Shock.

BACKGROUND: A retrospective study was conducted to investigate the validity and the effectiveness of early empiric antibiotic and de-escalation therapy for the treatment of severe sepsis and septic shock patients in the intensive care unit (ICU). METHODS: Patients admitted to the ICU at Chiba University Hospital from January 1, 2010, to December 31, 2012, for the treatment of severe sepsis or septic shock were selected for analysis. RESULTS: One-hundred and ten patients were enrolled for the analysis. Carbapenems were selected most frequently (57.3%), followed by cephalosporins (22.7%), and penicillins (21.8%). Empiric antibiotic therapy was appropriate for 85 (77.3%) patients. Mortality rates for patients with inappropriate empiric therapy was 36.8%, whereas mortality rates for patients with appropriate empiric therapy was 17.5%. Among the patients with appropriate empiric antibiotic administration, de-escalation was associated with lower mortality rates of 5.0% for severe sepsis and 9.7% for septic shock patients. The mortality rates for the no de-escalation group were 19.0% and 35.7%, respectively. CONCLUSION: Empiric antibiotic therapy was acceptable for severe sepsis and septic shock patients treated in the ICU. The appropriate selection of empiric antibiotics was related to a greater rate of de-escalation and better survival. The risk of multi-drug-resistant bacterial infections was not as high as expected, but will need further attention in the future.

Atraumatic splenic rupture cases presenting with hemorrhagic shock and coagulopathy treated by splenic artery occlusion using a microballoon catheter before splenectomy.

Atraumatic splenic rupture (ASR) is an uncommon pathologic condition in which bleeding from the spleen occurs for a variety of nontraumatic reasons. While the current trend in traumatic splenic rupture is nonoperative management including transcatheter arterial embolization, the current recommendation for the treatment of most patients with ASR is splenectomy. In this report, we describe two cases of ASR presenting with hemorrhagic shock and complicated by anticoagulation therapy. In patients with severe hemorrhagic shock and coagulopathy, a damage control strategy is recommended. Our successful treatment of these patients included a three-step strategy as a damage control: (i) rapid transient hemostasis by splenic artery occlusion using a microballoon catheter, (ii) damage control resuscitation and (iii) splenectomy as a definitive hemostatic treatment.