Hip Fractures
Conditions
Keywords
Perioperative outcomes
Brief summary
HIP ATTACK is an international randomized controlled trial of 3000 patients with a hip fracture that requires a surgical intervention. This trial will determine the effect of accelerated medical clearance and accelerated surgery compared to standard care on the 90-day risk of mortality and major perioperative complication (i.e., a composite of mortality, nonfatal myocardial infarction, nonfatal pulmonary embolism, nonfatal pneumonia, nonfatal sepsis, nonfatal stroke, and nonfatal life-threatening and major bleeding).
Interventions
Rapid medical clearance with targeted arrival to the operating room within 6 hours of diagnosis of a hip fracture requiring surgical repair.
Sponsors
Population Health Research Institute
Hamilton Health Sciences Corporation
McMaster University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age ≥45 years; and * diagnosis of hip fracture during working hours with a low-energy mechanism (i.e., falling from standing height) requiring surgery.
Exclusion criteria
* patients requiring emergent surgery or emergent interventions for another reason (e.g., subdural hematoma, abdominal pathology requiring urgent laparotomy, acute limb ischemia, other fractures or trauma requiring emergent surgery, necrotising fasciitis, coronary revascularization, pacemaker-implantation); * open hip fracture; * bilateral hip fractures; * peri-prosthetic fracture; * therapeutic anticoagulation not induced by a Vitamin K Antagonist, unfractionated heparin, (e.g., administration of therapeutic Low Molecular Weight Heparin (LMWH) (\>6,000 u/24h) in the 24 hours prior to enrolment, or intake of any other non-reversible oral anticoagulant(s) for which there is no reversing agent available * patients on a therapeutic vitamin K antagonist with a history of heparin induced thrombocytopenia (HIT); * patients refusing participation; or * patients previously enrolled in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite - major perioperative complication | 90 days | Composite of mortality, nonfatal myocardial infarction, nonfatal pulmonary embolism, nonfatal pneumonia, nonfatal sepsis, nonfatal stroke, and nonfatal life-threatening and major bleeding |
| Mortality | 90 days | All-cause mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Non-vascular mortality | 90 days and 1 year | Death due to non-vascular cause |
| Myocardial infarction | 90 days and 1 year | Myocardial infarction |
| Cardiac revascularization procedure | 90 days and 1 year | i.e., percutaneous coronary intervention \[PCI\] or coronary artery bypass grafting \[CABG\] surgery |
| New congestive heart failure | 90 days and 1 year | New congestive heart failure |
| New clinically important atrial fibrillation | 90 days | New clinically important atrial fibrillation |
| Nonfatal cardiac arrest | 30 days and 1 year | Nonfatal cardiac arrest |
| Stroke | 90 days and 1 year | Stroke |
| Peripheral arterial thrombosis | 90 days and 1 year | Peripheral arterial thrombosis |
| Pulmonary embolism | 90 days and 1 year | Pulmonary embolism |
| Deep venous thrombosis | 90 days and 1 year | Deep venous thrombosis |
| Pneumonia | 90 days and 1 year | Pneumonia |
| Sepsis | 90 days and 1 year | Sepsis |
| Infection | 90 days | Infection |
| Life-threatening bleeding | 90 days | Life-threatening bleeding |
| Major bleeding | 90 days | Major bleeding |
| New acute renal failure requiring dialysis | 90 days and 1 year | New acute renal failure requiring dialysis |
| Peri-prosthetic fracture | 90 days and 1 year | Peri-prosthetic fracture |
| Prosthetic hip dislocation | 90 days and 1 year | Prosthetic hip dislocation |
| All-cause mortality | 90 days and 1 year | Death due to all causes |
| Hip re-operation | 30 days and 1 year | Hip re-operation |
| Time to first mobilization | 90 days | Time to first mobilization |
| Length of hospital stay | 90 days | Length of hospital stay |
| Length of critical care stay | 90 days | Length of critical care stay |
| Length of rehabilitation stay | 90 days | Length of rehabilitation stay |
| New residence in a nursing home | 90 days and 1 year | New residence in a nursing home |
| Functional Independence Measure (FIM™) | 30 days and 1 year | Functional Independence Measure (FIM™) |
| SF-36 score | 30 days and 1 year | SF-36 score |
| Delirium within 7 days of randomization | 7 days | Delirium within 7 days of randomization |
| Hospital readmission | 90 days and 1 year | Hospital readmission |
| New pressure ulcers | 90 days | New pressure ulcers |
| Incisional pain | 30 days | Incisional pain |
| Chronic incisional pain | 1 year | Chronic incisional pain |
| Acute Kidney Injury | 90 Day | Acute Kidney Injury |
| Mortality and Institutionalization status of dependents | 30 Days | Mortality and Institutionalization status of dependents |
| Economic Analysis | 90 Days and 1 Year | Economic Analysis |
| Health System Utilization, Long Term Follow up | 2, 5, 10 Years | Health System Utilization, Long Term Follow up |
| Implant failure | 90 days and 1 year | Implant failure |
| Vascular mortality | 90 days and 1 year | Death due to vascular cause |
Countries
Belgium, Canada, China, Colombia, France, Hong Kong, India, Italy, Malaysia, Netherlands, Pakistan, Poland, South Africa, Spain, Thailand, United Kingdom, United States
Outcome results
None listed