NCT02027896CompletedNot Applicable
HIP Fracture Accelerated Surgical TreaTment And Care tracK (HIP ATTACK) Trial
McMaster University105 sites in 13 countries3,001 target enrollmentStarted: March 14, 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- McMaster University
- Enrollment
- 3,001
- Locations
- 105
- Primary Endpoint
- Composite - major perioperative complication
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 45 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
Composite - major perioperative complication
Time Frame: 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
Time Frame: 90 days
All-cause mortality
Secondary Outcomes
- Sepsis(90 days and 1 year)
- Major bleeding(90 days)
- Deep venous thrombosis(90 days and 1 year)
- All-cause mortality(90 days and 1 year)
- Cardiac revascularization procedure(90 days and 1 year)
- New congestive heart failure(90 days and 1 year)
- Stroke(90 days and 1 year)
- Peri-prosthetic fracture(90 days and 1 year)
- Vascular mortality(90 days and 1 year)
- Non-vascular mortality(90 days and 1 year)
- Myocardial infarction(90 days and 1 year)
- New clinically important atrial fibrillation(90 days)
- Nonfatal cardiac arrest(30 days and 1 year)
- Peripheral arterial thrombosis(90 days and 1 year)
- Pulmonary embolism(90 days and 1 year)
- Prosthetic hip dislocation(90 days and 1 year)
- Implant failure(90 days and 1 year)
- Length of rehabilitation stay(90 days)
- SF-36 score(30 days and 1 year)
- Delirium within 7 days of randomization(7 days)
- Chronic incisional pain(1 year)
- Economic Analysis(90 Days and 1 Year)
- Pneumonia(90 days and 1 year)
- Functional Independence Measure (FIM™)(30 days and 1 year)
- New pressure ulcers(90 days)
- Mortality and Institutionalization status of dependents(1 Year)
- Infection(90 days)
- Life-threatening bleeding(90 days)
- Time to first mobilization(90 days)
- New acute renal failure requiring dialysis(90 days and 1 year)
- Hip re-operation(30 days and 1 year)
- Length of hospital stay(90 days)
- New residence in a nursing home(90 days and 1 year)
- Hospital readmission(90 days and 1 year)
- Acute Kidney Injury(1 Year)
- Length of critical care stay(90 days)
- Incisional pain(30 days)
- Health System Utilization, Long Term Follow up(2, 5, 10 Years)
Investigators
Study Sites (105)
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