Accelerated care versus standard care among patients with hip fracture: the HIP ATTACK pilot trial

Abstract

Background: A hip fracture causes bleeding, pain and immobility, and initiates inflammatory, hypercoagulable, catabolic and stress states. Accelerated surgery may improve outcomes by reducing the duration of these states and immobility. We undertook a pilot trial to determine the feasibility of a trial comparing accelerated care (i.e., rapid medical clearance and surgery) and standard care among patients with a hip fracture.

Methods: Patients aged 45 years or older who, during weekday, daytime working hours, received a diagnosis of a hip fracture requiring surgery were randomly assigned to receive accelerated or standard care. Our feasibility outcomes included the proportion of eligible patients randomly assigned, completeness of follow-up and timelines of accelerated surgery. The main clinical outcome, assessed by data collectors and adjudicators who were unaware of study group allocations, was a major perioperative complication (i.e., a composite of death, preoperative myocardial infarction, myocardial injury after noncardiac surgery, pulmonary embolism, pneumonia, stroke, and life-threatening or major bleeding) within 30 days of randomization.

Results: Of patients eligible for inclusion, 80% consented and were randomly assigned to groups (30 to accelerated care and 30 to standard care) at 2 centres in Canada and 1 centre in India. All patients completed 30-day follow-up. The median time from diagnosis to surgery was 6.0 hours in the accelerated care group and 24.2 hours in the standard care group (p < 0.001). A major perioperative complication occurred in 9 (30%) of the patients in the accelerated care group and 14 (47%) of the patients in the standard care group (hazard ratio 0.60, 95% confidence interval 0.26-1.39).

Interpretation: These results show the feasibility of a trial comparing accelerated and standard care among patients with hip fracture and support a definitive trial.

Trial registration: ClinicalTrials.gov, no. NCT01344343.

Figure 1:

Initial and amended treatment pathways. The protocol was amended to randomly assign patients immediately on diagnosis so that only those assigned to early surgery received expedited medical clearance. ED = emergency department.

Figure 2:

Flow of patients through the trial.

Figure 3:

Kaplan–Meier curves of the composite endpoint of major perioperative complications (i.e., a composite of death, preoperative myocardial infarction, myocardial injury after noncardiac surgery, stroke, pulmonary embolism, pneumonia, and major or life-threatening bleeding). Note: p = 0.2.