Randomised controlled trial comparing intraoperative cell salvage and autotransfusion with standard care in the treatment of hip fractures: a protocol for the WHITE 9 study

Introduction
People who sustain a hip fracture are typically elderly, frail and require urgent surgery. Hip fracture and the urgent surgery is associated with acute blood loss, compounding patients’ pre-existing comorbidities including anaemia. Approximately 30% of patients require a donor blood transfusion in the perioperative period. Donor blood transfusions are associated with increased rates of infections, allergic reactions and longer lengths of stay. Furthermore, there is a substantial cost associated with the use of donor blood. Cell salvage and autotransfusion is a technique that recovers, washes and transfuses blood lost during surgery back to the patient. The objective of this study is to determine the clinical and cost effectiveness of intraoperative cell salvage, compared with standard care, in improving health related quality-of-life of patients undergoing hip fracture surgery.

Methods and analysis
Multicentre, parallel group, two-arm, randomised controlled trial. Patients aged 60 years and older with a hip fracture treated with surgery are eligible. Participants will be randomly allocated on a 1:1 basis to either undergo cell salvage and autotransfusion or they will follow the standard care pathway. Otherwise, all care will be in accordance with the National Institute for Health and Care Excellence guidance. A minimum of 1128 patients will be recruited to obtain 90% power to detect a 0.075-point difference in the primary endpoint: EuroQol-5D-5L HRQoL at 4 months post injury. Secondary outcomes will include complications, postoperative delirium, residential status, mobility, allogenic blood use, mortality and resource use.

Ethics and dissemination
NHS ethical approval was provided on 14 August 2019 (19/WA/0197) and the trial registered (ISRCTN15945622). After the conclusion of this trial, a manuscript will be prepared for peer-review publication. Results will be disseminated in lay form to participants and the public.

Trial registration number
ISRCTN15945622.

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Giugno 2022

Intensive Versus Standard Treatment of Hyperglycemia in Acute Ischemic Stroke Patient: A Randomized Clinical Trial Subgroups Analysis

Stroke, Ahead of Print. Background:Benefit from blood glucose (BG) control during acute ischemic stroke may depend on glycemic parameters. We evaluated for associations between the SHINE (Stroke Hyperglycemia Insulin Network Effort) randomized treatment group and the SHINE predefined 90-day functional outcome, within-patient subgroups defined by various glycemic parameters.Methods:The SHINE Trial randomized 1151 patients within 12 hours with acute ischemic stroke and hyperglycemia to standard (target BG 80–179 mg/dL) or intensive (target BG 80–130 mg/dL) BG control for 72 hours. We predefined 6 glycemic parameters: acute BG level, absence versus presence of diagnosed and undiagnosed diabetes, hemoglobin A1c, glycemic gap (acute BG–average daily hemoglobin A1c based BG), stress hyperglycemia ratio (acute BG/average daily hemoglobin A1c based BG), and BG variability (SD). Favorable functional outcome was defined by the SHINE Trial and based on the modified Rankin Scale score at 90 days, adjusted for stroke severity. We computed relative risks adjusted for baseline stroke severity and thrombolysis use.Results:Likelihood for favorable outcome was lowest among patients with undiagnosed diabetes compared to patients with true nondiabetes (adjusted relative risk, 0.42 [99% CI, 0.19–0.94]). We did not find any relationship between the favorable outcome rate and baseline BG or any of the glycemic parameters. No differences between SHINE treatment groups were identified among any of these patient subgroups.Conclusions:In this exploratory subgroup analysis, intensive versus standard insulin treatment of hyperglycemia in acute ischemic stroke patient subgroups, did not influence the 90-day functional outcomes, nor did we identify associations between these glycemic parameters and 90-day functional outcomes.

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Marzo 2022

Abstract WP30: Zoom Or In The Room, Meeting The Stroke Education Standard

Stroke, Volume 53, Issue Suppl_1, Page AWP30-AWP30, February 1, 2022. Background:Comprehensive Stroke Center nurses are required to receive 8 hours of stroke education annually; meeting this objective has been a challenge for administrators due to staffing shortages as well as the need to social distance during the COVID pandemic prompting virtual learning as a method to meet these standards. Web based courses often lack the multiplicity of diverse learning modalities needed for success.Purpose:Our objective was to provide a meaningful way to provide stroke education using the six perceptual modalities needed for adult learning which included visual, aural, printed, tactile, interactive, and kinesthetic learning.Methods:The stroke administrative team conducted a needs analysis based on nursing requests, outcome metrics, and requirements of the Joint Commission. A hybrid approach was delivered to the staff using four hours of classroom didactics, three hours of online classes, and one hour of education at hospital skills fairs, and unit meetings. Classrooms utilized social distancing, requiring multiple classes to be offered.Results:Nurses were surveyed with a 12 question Likert scale about how well they were prepared to integrate learned material into clinical practice comparing both virtual and live modalities. They were also asked about individual learning modalities. Twenty-five people responded to the survey. Only 12% of virtual learner respondents felt strongly prepared to care for stroke patients compared to 76% of classroom learners. Seventy-nine percent preferred classroom learning compared to 17% virtual, with a 4% hybrid preference. Learning preferences were multifactorial for visual, aural, printed, tactile, interactive, and kinesthetic learning being 95%, 48%, 56%, 40%, 11%, and 20% respectively.Conclusions:Virtual learning provides solutions in difficult situations, however classroom education is the preferred method of learning for healthcare professionals delivering evidenced based care for acute stroke patients. Planning committees should at least consider a hybrid approach that offer classroom time to caregivers.

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Febbraio 2022