Rationale and design of the HIP fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) Trial: a protocol for an international randomised controlled trial evaluating early surgery for hip fracture patients

Abstract

IntroductionAnnually, millions of adults suffer hip fractures. The mortality rate post a hip fracture is 7%–10% at 30 days and 10%–20% at 90 days. Observational data suggest that early surgery can improve these outcomes in hip fracture patients. We designed a clinical trial—HIP fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) to determine the effect of accelerated surgery compared with standard care on the 90-day risk of all-cause mortality and major perioperative complications.Methods and analysisHIP ATTACK is a multicentre, international, parallel group randomised controlled trial (RCT) that will include patients ≥45 years of age and diagnosed with a hip fracture from a low-energy mechanism requiring surgery. Patients are randomised to accelerated medical assessment and surgical repair (goal within 6 h) or standard care. The co-primary outcomes are (1) all-cause mortality and (2) a composite of major perioperative complications (ie, mortality and non-fatal myocardial infarction, pulmonary embolism, pneumonia, sepsis, stroke, and life-threatening and major bleeding) at 90 days after randomisation. All patients will be followed up for a period of 1 year. We will enrol 3000 patients.Ethics and disseminationAll centres had ethics approval before randomising patients. Written informed consent is required for all patients before randomisation. HIP ATTACK is the first large international trial designed to examine whether accelerated surgery can improve outcomes in patients with a hip fracture. The dissemination plan includes publishing the results in a policy-influencing journal, conference presentations, engagement of influential medical organisations, and providing public awareness through multimedia resources.Trial registration numberNCT02027896; Pre-results.

Results after introduction of a hip fracture care pathway: comparison with usual care

“…A multicenter quality improvement study from 2018, comparing a care pathway with usual admission and care, found no differences in mortality or functional outcome (Panella et al 2018). An RCT on preoperative waiting time is being conducted and the results from that trial will probably elucidate this question (Borges et al 2019). Reduced preoperative waiting time may reduce the LOS, but we believe that the reduced LOS in the HFU was mainly due to improved capacity in the municipal health services (Table 3) (Monkerud and Tjerbo 2016).…”

Effects of accelerated versus standard care surgery on the risk of acute kidney injury in patients with a hip fracture: a substudy protocol of the hip fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) international randomised controlled trial

“…The HIP ATTACK trial is a multinational, parallel-group superiority randomised controlled trial of patients who present to the emergency department with a hip fracture requiring surgical repair. The main trial protocol is described elsewhere 6. Briefly, patients who sustained a hip fracture were randomly allocated (1:1) to receive accelerated medical assessment and surgical repair (with the goal of having the surgery performed within 6 hours after the orthopaedic diagnosis) or usual care (where a repair typically occurs 24–48 hours after diagnosis).…”

“…Patients were recruited from the emergency department. Eligibility criteria for the main HIP ATTACK trial are fully detailed in the published protocol 6. Eligible patients included those aged 45 years or older diagnosed with a hip fracture with a low-energy mechanism (eg, a fracture sustained from a fall not beyond standing height) requiring surgery.…”

“…Patients underwent medical clearance by an on-call medical specialist (ie, an internist, geriatrician, cardiologist or anaesthesiologist) who was able to quickly come to the emergency department and perform the assessment. Specialists used their own clinical judgement and weighed the potential risks and benefits of rapidly clearing patients for surgery 3 6. The patient’s orthopaedic surgeon and anaesthesiologist also had to agree that the patient was an appropriate surgical candidate.…”

“…Complications are common, and the 90-day risk of mortality is 10%–20%. Shortening the time to surgery shows promise for reducing patient morbidity and mortality,3–5 and this strategy is currently being tested in comparison with usual care in a multinational randomised controlled trial: the Hip fracture Accelerated surgical TreaTment And Care tracK (HIP ATTACK) trial 6. HIP ATTACK has two coprimary outcomes: the 90-day risk of (1) all-cause mortality and (2) major perioperative complications.…”