Neurocritical Patient Characteristics Related to Brain Death.

BACKGROUND: The lack of viable organs for transplantation led to the creation in Argentina of the Glasgow 7 Program based on the detection and follow-up of acute neurologic patients admitted with Glasgow scores ≤7 in selected hospitals. The objective of this study was to determine the likelihood of hospitalized acute neurologic patients progressing to brain death (BD) based on several variables, including age, sex, and admission diagnosis. METHODS: This study was a retrospective cohort analysis of data obtained from the SINTRA (Procurement and Transplantation National Information System) database between 2006 and 2015. Independent variables included the following: age, sex, and diagnosis at admission; ischemic stroke; spontaneous intracerebral hematoma (SIH); subarachnoid hemorrhage (SH); anoxia, meningitis; penetrating head injury (PHI); closed head injury; and tumors. A multivariate analysis was performed adjusting the diagnosis at admission according to age and sex. RESULTS: A total of 31,877 patients were included: 19,308 (61%) patients died and 9736 (30%) evolved to BD. Overall, 36% of women and 28% of men evolved to BD (relative risk, 0.87 [95% confidence interval (CI), 0.86-0.89]; P < .001). In the multivariate analysis adjusted for age and sex, we observed the following: SIH OR, 1.79 (95% CI, 1.69-1.9; P < .001); ischemic stroke OR, 0.82 (95% CI, 0.73-0.92; P < .001); SH OR, 2.33 (95% CI, 2.16-2.52; P < .001); anoxia OR, 0.71 (95% CI, 0.64-0.79; P < .001); closed head injury OR, 0.41 (95% CI, 0.38-0.43; P < .001); PHI OR, 2.64 (95% CI, 2.38-2.94; P < .001); and tumors OR, 1.07 (95% CI, 0.93-1.24; P = .31). CONCLUSIONS: Thirty percent of the patients who entered the Glasgow 7 Program evolved with BD. The characteristics most likely to result in BD were age, female sex, PHI, SH, and SIH.

Sterility and Safety Validation for Transport Packaging of Organs and Tissues.

The bags used in the transport of organs and tissues must be sterile, nontoxic, pyrogen free, and must serve as a barrier throughout their useful life. The goal of this study was to show the sterility, safety, and functionality of the bags subjected to irradiation, through validated procedures and techniques. The selected sterilization method was the use of gamma radiation. The sterilization dose was determined based on validated standards for the sterilization of medical products, ISO 11137-2: 2013 and ISO/TS 13004: 2013, using the Verification Dose Maximum method on samples belonging to 3 manufacturing lots. The ISO 10993-5: 2009 standard was used in the cytotoxicity tests, by means of extracts test and quantitative technique of MTT, 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide. The tests to determine the expiration date of the kit were performed by ASTM F1980, accelerated aging, and ASTM D3078 to evaluate hermeticity. The irradiation dose validated to reach the required sterility safety level was 22.5 kGy. The constituent materials and the sterilization method do not generated cellular toxicity, and the product was not modified during the simulated time of 5 years. Sterilization by irradiation is a method that leaves no residue, does not harm the properties of the material because it is conducted in cold, and as the sterilizing agent, the energy absorbed by the product is highly penetrating and can be treated in its final packaging, with no risk of postcontamination. It is for this reason that it is prioritized over other methods of sterilization.