Background This prospective study evaluated the effect of routine, uncontrolled, Israeli field storage conditions on the safety and efficacy of Lyo‐Plas N Freeze‐Dried Plasma (FDP) at the end of the manufacturer's shelf life, and up to 24 months post expiry. Clotting factors V, VIII and XI, proteins S, C, fibrinogen, PTT, ATIII, VWF, and INR as well as TEG, DDM, residual moisture, pH, and sterility of FDP returned from field units after uncontrolled storage were evaluated. Study Design and Methods Parameters measured at the end of manufacturer shelf life, as well as 6, 12, 18, and 24 months after expiry, were compared to those of freshly supplied FDP doses. Results Changes were found when comparing freshly supplied FDP to all field‐stored groups in INR, PT, PTT, pH, fibrinogen, and factor VIII. A significant change was also seen in Factor XI in the 12, 18, and 24 months post‐expiry samples, Factor V and R in the 24 months post‐expiry samples, MA in the 12, 24 months post‐expiry group, and Protein C in the 18 months post‐expiry group. An increase in the residual moisture from 0.90% in freshly supplied FDP to 1.35% in 24 months post‐expiry FDP.; all p < .05. No growth was found in sterility analysis. Conclusion Despite uncontrolled field storage conditions, the findings demonstrate that the safety and efficacy of FDP units, stored in uncontrolled conditions are only slightly affected, even beyond their expiration date. This information allows consideration of possibly extending the shelf life.

Background Limiting life-sustaining treatment (LST) in the intensive care unit (ICU) by withholding or withdrawing interventional therapies is considered appropriate if there is no expectation of beneficial outcome. Prognostication for very old patients is challenging due to the substantial biological and functional heterogeneity in that group. We have previously identified seven phenotypes in that cohort with distinct patterns of acute and geriatric characteristics. This study investigates the relationship between these phenotypes and decisions to limit LST in the ICU. Methods This study is a post hoc analysis of the prospective observational VIP2 study in patients aged 80 years or older admitted to ICUs in 22 countries. The VIP2 study documented demographic, acute and geriatric characteristics as well as organ support and decisions to limit LST in the ICU. Phenotypes were identified by clustering analysis of admission characteristics. Patients who were assigned to one of seven phenotypes (n = 1268) were analysed with regard to limitations of LST. Results The incidence of decisions to withhold or withdraw LST was 26.5% and 8.1%, respectively. The two phenotypes describing patients with prominent geriatric features and a phenotype representing the oldest old patients with low severity of the critical condition had the largest odds for withholding decisions. The discriminatory performance of logistic regression models in predicting limitations of LST after admission to the ICU was the best after combining phenotype, ventilatory support and country as independent variables. Conclusions Clinical phenotypes on ICU admission predict limitations of LST in the context of cultural norms (country). These findings can guide further research into biases and preferences involved in the decision-making about LST. Trial registration Clinical Trials NCT03370692 registered on 12 December 2017.

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