HIP Fracture Accelerated Surgical TreaTment And Care tracK (HIP ATTACK) Trial (HIPATTACK)
There is preliminary evidence that suggests early surgical treatment of a hip fracture may improve patients' outcomes. The investigators propose to do a pilot randomized controlled trial (RCT) to assess the feasibility of a large RCT comparing accelerated surgical repair (i.e. surgery within 6 hours of a hip fracture diagnosis) versus standard care (typically surgery after 36-48 hours).
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
|Official Title:||HIP Fracture Accelerated Surgical TreaTment And Care tracK (HIP ATTACK) Trial - Feasibility Pilot|
- Feasibility [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Feasibility defined as:
- ability to recruit 60 patients in 18 months
- ability to achieve arrival in the operating room within 6 hours of diagnosis in >=80% of the patients randomized to accelerated surgery
- ability to achieve accelerated surgery in a timely manner
- ability to achieve medical clearance in a timely manner
- resource requirements to achieve recruitment and follow up
- All-cause mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Length of hospital stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Length of intensive care unit stay [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Length of stay in rehabilitation facility [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- New admission to a long-term care facility [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Functional Independence Measure (motor domain) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- Short form health survey (SF-36) (acute form) [ Time Frame: 30 days ] [ Designated as safety issue: No ]Acute form = 1 week recall
- Delirium [ Time Frame: 7 days after randomization ] [ Designated as safety issue: No ]Delirium, as defined by the Confusion Assessment Method
- Pre-operative Myocardial Infarction [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
- Nonfatal Stroke [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
- Nonfatal Pneumonia [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
- Nonfatal Pulmonary Embolism [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
- Sepsis [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
- New Congestive Heart Failure [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
- Nonfatal Cardiac Arrest [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
- Nonfatal myocardial injury after non cardiac surgery (MINS) [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
Myocardial cell injury caused by ischemia, which occurs within 30 days after noncardiac surgery and has short-term prognostic relevance.
The diagnostic criteria for MINS is within the first 30-days after noncardiac surgery a troponin T value ≥0.03 ng/mL that is felt do to ischemia. MINS does not include perioperative myocardial injury that is due to pulmonary embolism, sepsis, cardioversion, a known troponin antibody or known chronically elevated troponin measurements, or another known nonischemic etiology.
- Composite Endpoint [ Time Frame: 30 Days ] [ Designated as safety issue: No ]Composite Outcome of of all-cause mortality, nonfatal pre-operative myocardial infarction, nonfatal myocardial injury after noncardiac surgery (MINS), nonfatal pulmonary embolism, nonfatal pneumonia, nonfatal life-threatening or major bleeding, and nonfatal stroke at 30 days.
- Major or Life-threatening Bleeding [ Time Frame: 30 Days ] [ Designated as safety issue: No ]
|Study Start Date:||July 2011|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
Experimental: Accelerated hip fracture surgery
Arrival in the operating room within 6 hours of diagnosis of a hip fracture requiring surgical repair
Other: Accelerated surgical hip fracture repair
Accelerated hip fracture surgery defined as arrival in the operation room within 6 hours of diagnosis of a hip fracture requiring surgery
No Intervention: Standard care
Surgical hip fracture repair according to the standard timing
Hip fractures have devastating consequences: the 30-day mortality rate for men is 9% and for women is 5%, and the risk of disability is substantial. Even among patients who are community-dwelling prior to their hip fracture, 11% are bed-ridden and 16% are in a long-term care facility after one year.
The trauma associated with a hip fracture results in pain, bleeding, and immobility. These factors initiate inflammatory, hypercoaguable, stress, and catabolic states that can cause medical complications, including death. Proposed mechanisms for increased mortality and morbidity associated with delayed surgery include 1) complications related to a protracted immobilization (e.g. venous thromboembolism, atelectasis and pneumonia, urinary tract infections, pressure ulcers, and muscle mass loss) and 2) increased cardiovascular events.
Delay in surgery may result in protracted immobility and the associated complications, as well as prolonged exposure to the hypercoagulable-inflammatory-sympathetic state which may increase cardiovascular events. Observational data suggests that these mechanisms are indeed important: delayed surgical repair is associated with increased mortality and morbidity after a hip fracture.
A systematic review and meta-analysis of observational studies addressed the impact of timing of surgery on the outcome after hip fracture. Five studies reported adjusted measures for mortality. The pooled estimate, based on 721 deaths in 4,208 patients, suggested that early surgical treatment (i.e. within the cut-off of the individual studies) of hip fractures was associated with a significant reduction in mortality (adjusted risk ratio [RR] 0.81, 95% confidence interval [CI] 0.68-0.96).
It is possible that these observational data substantially underestimates the real potential of early surgery. The reason is that the "early surgery" in these studies occurred within 24, 48 or 72 hours. If surgery could be uniformly undertaken within 6 hours, given the potential benefits of earlier mobilization and minimization of the period of the inflammatory hypercoagulable state, the benefits might be substantially greater. The substantial impact of treatment of acute myocardial infarction (MI) or stroke within hours adds credence to this possibility.
Despite the evidence, and the possibility that a larger effect might result from even earlier surgery, current data supports only weak inferences. The evidence relies on observational data and is therefore susceptible to residual confounding. The strength of inference from current evidence does not lay a sufficient solid base to justify the substantial system modification required to facilitate accelerated surgical access for all hip fracture patients.
The main factors that cause surgical delay after a hip fracture are: 1) the patient presents with comorbidities and surgery is deferred for preoperative diagnostics, risk stratification, and medical optimization ("medical clearance") and 2) surgical operating room and staff resources are not available because hip fractures have low priority in urgent surgery lists ("queuing"). Both medical clearance and queuing are modifiable issues - addressing these obstacles has the potential to substantially reduce surgical wait times.
Our ultimate goal is to undertake a large multicentre randomized controlled trial (RCT) of accelerated surgical care (i.e., goal of surgery within 6 hours of diagnosis) versus usual timing of surgery among elderly adults diagnosed with a hip fracture. This protocol is for a pilot RCT that will inform the feasibility of undertaking a large RCT.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01344343
|Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8L 2X2|
|St. Joseph Healthcare Hamilton|
|Hamilton, Ontario, Canada, L8N 4A6|
|Sancheti Institute for Orthopaedics and Rehabilitation|
|Pune, Maharashtra, India, 411005|
|Principal Investigator:||Philip J Devereaux, MD, PhD||Population Health Research Institute, McMaster University|
|Principal Investigator:||Mohit Bhandari, MD, MSc||Hamilton Health Sciences Corporation|