BACKGROUND: One of the medical areas where errors can have more serious consequences is the process of blood transfusion. We used failure mode and effect analysis (FMEA) for evaluating potential failures and improving transfusion safety in a medium-size urban hospital with a highly complex transfusion service.STUDY DESIGN AND METHODS: Each failure mode was evaluated using the likelihood of occurrence, severity of the effect, and probability of detection. The obtained results allowed each failure to be prioritized and decisions to be made in an organized manner to determine solutions. We define measures and indicators that allow the comparison of their results in a longer time period than most of the previous studies.ABBREVIATIONS: BT = blood transfusion; FMEA = failure mode and effect analysis; RPNs = risk priority numbers; TCD = transfusion control document.From the
Objectives
to determine the safety and effect of intravenous iron sucrose on functional outcomes, delirium, nosocomial infections and transfusion requirements in older patients with hip fracture.
Design
single-centre randomised, double-blind, placebo-controlled clinical trial.
Setting and participants
orthogeriatric share care service at an academic tertiary care hospital. A total of 253 patients were recruited: 126 patients were assigned to intravenous iron and 127 to placebo.
Methods
on days 1, 3 and 5 after admission, the iron group received 200 mg Venofer® (iron sucrose) in 100 ml saline and the placebo group 100 ml saline. The primary outcome was absolute functional gain, considered as Barthel index (BI) at discharge minus BI on admission. Secondary outcomes included incidence of postoperative delirium according to the confusion assessment method, proportion of patients recovering prior functional status at 3 months, postoperative transfusion requirements, haemoglobin at 3 months, incidence of nosocomial infections and safety.
Results
the median participant age was 87 (interquartile range, 82.5–91.5) years. Most patients were female (72.7%), and the median previous BI was 81(59–95). No significant effect of intravenous iron was observed for the primary outcome: the median AFG score was 17.1 points (4.8–23.3) in the intravenous iron group and 16 points (6–26) in the placebo group (P = 0.369). No significant treatment effects were observed for other functional outcomes or secondary end points.
Conclusion
while we found no impact of intravenous iron sucrose on functional recovery, incidence of postoperative delirium, transfusion requirements, haemoglobin at 3 months, mortality and nosocomial infections rates in older patients with hip fracture, we did find that the intervention was safe.
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