Every year, roughly 70,000 UK hip fracture patients receive blood-thinning drugs to prevent dangerous clots, but doctors still disagree on which drug works best. This uncertainty matters because hip fracture patients are at high risk of venous thromboembolism (VTE)—a major cause of illness and death. Current guidelines from NICE offer no clear first-line option, leading to variation in practice across hospitals. The existing evidence, drawn partly from elective hip surgery trials, is inconsistent and leaves a gap in knowledge. The trial will compare two standard strategies: low molecular weight heparin (LMWH) as the control, versus aspirin as the test treatment. It will enrol adults aged 60 and older with hip fractures across UK hospitals, using registry data to track outcomes. The primary measure is hospital-associated VTE within 90 days; safety is assessed by major bleeding within 28 days. A parallel economic analysis will model long-term costs and consequences, including post-thrombotic syndrome and pulmonary hypertension. If aspirin proves non-inferior to LMWH, NICE estimates the NHS could save £27 million annually. The results will directly inform national guidance, potentially changing routine prophylaxis for tens of thousands of patients each year.
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NICE RESEARCH PRIORITY What is the clinical and cost effectiveness of aspirin alone versus other pharmacological strategies for people with fragility fractures of the hip? BACKGROUND Hip fracture is one of the biggest challenges facing patients and healthcare systems. In the UK, and across the world, hip fracture is the commonest fragility fracture that requires inpatient hospital treatment. There are approximately 70,000 hip fractures in the UK every year, accounting for £1.1 billion in hospital care costs and consuming 2% of the total NHS budget. Patients sustaining hip fracture are known to be at considerably increased risk of developing a venous thromboembolism (VTE) compared with a matched, uninjured, population. VTE is a major cause of morbidity and mortality. All patients admitted to hospital, including those with a hip fracture, are risk assessed and those at risk are given thromboprophylaxis according to National Institute of Health and Care Excellence (NICE) guidelines. The existing literature from studies of people with hip fracture, and heterogeneity between effect estimates from randomised trials in elective hip surgery, means that NICE and global opinion leaders have been unable to agree a preferred first-line prophylaxis strategy. Consequently, variation exists in national and international practice for prophylaxis for people with hip fracture. In 2018 NICE proposed a ‘Top Five’ research recommendation to address this major clinical uncertainty. AIM To determine whether a first-line thromboprophylaxis management strategy including aspirin is non-inferior in terms of clinical effectiveness and safety, and cost-effective, relative to a first-line VTE thromboprophylaxis management strategy including low molecular weight heparin (LMWH) in adults aged over 60 years with a hip fracture. DESIGN A multicentre, pragmatic, standard-of-care controlled, cluster (hospital) randomised, single crossover, registry-enabled noninferiority trial and parallel economic analysis. METHODS Setting: UK hospitals treating people with acute hip fracture. Population: Adults 60 years and older sustaining fragility hip fracture identified by their entry into UK hip registries. Interventions: First-line thromboprophylaxis management strategy including LMWH (control) versus first-line thromboprophylaxis management strategy including aspirin (test). Outcomes: Primary-efficacy: hospital associated VTE events within 90 days, Primary-safety: major bleeding events within 28 days; Secondary: all-cause mortality at 90 days, cause-specific mortality: VTE at 90 days, bleeding and cardiovascular at 28 days. Primary within-trial analysis: To present risk differences for each comparison on an intention to treat basis. Modelling: Markov model, informed by the trial effect estimates, to model cost-effectiveness and long term outcomes such as post thrombotic syndrome and pulmonary hypertension. TIMELINES FOR DELIVERY Study duration will be 45 months in total with the pilot due to start 1/04/2024 and completion on 01/01/2028 (6-month set-up, 12-month pilot phase, 12-month recruitment phase, 9-month data curation (funding freeze), 6-month analysis and study close). ANTICIPATED IMPACT & DISSEMINATION Our findings will inform national guidance. If aspirin were non-inferior NICE estimate a £27M annual saving. We will publish in medical journals and disseminate our findings via supporting organisations, and provide regular updates to the public throughout the project.
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