A large clinical trial across 30 NHS hospitals will test whether giving hip fracture patients more blood transfusions than current guidelines recommend can prevent heart attacks and deaths. This matters because hip fracture patients are typically older and frail, and anaemia after surgery puts stress on the heart. Current UK guidance recommends a restrictive transfusion threshold, but many clinicians already use a more liberal approach because the evidence for this specific population is weak and uncertain. The trial directly compares the two strategies to settle the debate. If the liberal approach proves superior, it could change national transfusion guidelines and reduce cardiac complications in tens of thousands of older patients each year. If the restrictive approach is equally safe, it would confirm current practice and save blood products and NHS costs. The trial also includes a health economic analysis to determine which strategy offers better value for money.
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Design: Multi-centre, participant-blind, parallel-group randomised controlled clinical and cost effectiveness trial with internal pilot. Setting: 30 NHS hospitals Population: Adults aged 60 years or older with hip fracture who become anaemic (Hb less than 90 g.L-1) during the seven days following surgery will be eligible for enrolment. Patients receiving palliative care, who have life threatening haemorrhage at the time of screening, pre-randomisation acute coronary syndrome or objection to receiving RBC transfusion will be excluded. Health technologies being assessed: “Liberal” transfusion threshold of Hb 90 g.L-1 (target Hb 90-110 g.L-1) for duration of acute hospital stay. This is more liberal than current guidance but consistent with practice of many clinicians in this population. Control group treatment: “Restrictive” transfusion threshold of 75 g.L-1 (target of 75-90 g.L-1) for duration of acute hospital stay. This is consistent with current NICE guidance. Many clinicians and published reviews note uncertainty and low quality of evidence for this population. Costs and Outcomes: The primary outcome will be death or major adverse cardiac events (MACE) within 30 days of surgery. MACE will be defined as any combination of the following: death, myocardial Infarction, new arrhythmia, cardiac or respiratory arrest, cardiogenic pulmonary oedema. An ordinal ranking approach will be used in analysis. To maximize validity and consistency, all patients will have troponin measured at randomisation, day 1 and 5 post-randomisation and 12-lead ECGs will be performed at baseline and day 5. Primary outcome will be determined by an expert adjudication team blinded from group allocation. The secondary outcomes at 30 days will be: all-cause mortality, myocardial injury after non-cardiac surgery, individual MACE components; other complications (acute kidney injury (AKI), infection, delirium); proportion of patients transfused; volume of blood transfused; discharge destination; hospital length of stay; and, healthcare related quality of life (HRQoL) using EQ-5D-5L. The secondary outcomes at 120 days will be: secondary care costs up to 120 days; HRQoL (EQ-5D and SF-12), unplanned hospital readmissions within 120 days, mobility, residential status. Health Economic evaluation: We will undertake a within-trial cost-consequence analysis and a long run post-surgery care costs analysis. Process evaluation: We will undertake a process evaluation in the study pilot phase to examine barriers to recruitment and protocol compliance. Follow up: 120 days post randomisation. Sample size: 982 patients per group, giving a total sample size 1,964 participants (allowing 10% dropout rate). Based on pilot data and expert opinion we expect incidence rate for the primary outcome of 15% at 30 days and an absolute risk reduction (ARR) of 5% in the primary outcome to be a realistic meaningful effect size that would change practice (33% Relative RR; Number Needed to Treat, 20). Project time frames: The total project duration is 48 months. In month 1-12 we will undertake approvals, set-up and 10-site internal pilot. In months 13-24 we will set-up the remaining 20 sites. Month 25-36: will be the main recruitment phase. In months 37-48 we will complete follow-up, analysis, report writing. Expertise: The proposed trial has been developed by an experienced multi-professional team with patient involvement throughout.
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