HIP Fracture Accelerated Surgical TreaTment And Care tracK (HIP ATTACK) Trial
- Conditions
- Hip Fractures
- Registration Number
- NCT02027896
- Lead Sponsor
- McMaster University
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3001
- age ≥45 years; and
- diagnosis of hip fracture during working hours with a low-energy mechanism (i.e., falling from standing height) requiring surgery.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Acute Kidney Injury 1 Year Acute Kidney Injury
Major bleeding 90 days Major bleeding
All-cause mortality 90 days and 1 year Death due to all causes
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
Stroke 90 days and 1 year Stroke
Deep venous thrombosis 90 days and 1 year Deep venous thrombosis
Peri-prosthetic fracture 90 days and 1 year Peri-prosthetic fracture
Vascular mortality 90 days and 1 year Death due to vascular cause
Non-vascular mortality 90 days and 1 year Death due to non-vascular cause
Myocardial infarction 90 days and 1 year Myocardial infarction
New clinically important atrial fibrillation 90 days New clinically important atrial fibrillation
Peripheral arterial thrombosis 90 days and 1 year Peripheral arterial thrombosis
Pulmonary embolism 90 days and 1 year Pulmonary embolism
Prosthetic hip dislocation 90 days and 1 year Prosthetic hip dislocation
Implant failure 90 days and 1 year Implant failure
Length of rehabilitation stay 90 days Length of rehabilitation stay
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
Chronic incisional pain 1 year Chronic incisional pain
Economic Analysis 90 Days and 1 Year Economic Analysis
Pneumonia 90 days and 1 year Pneumonia
Functional Independence Measure (FIM™) 30 days and 1 year Functional Independence Measure (FIM™)
New pressure ulcers 90 days New pressure ulcers
Mortality and Institutionalization status of dependents 1 Year Mortality and Institutionalization status of dependents
Infection 90 days Infection
Life-threatening bleeding 90 days Life-threatening bleeding
Time to first mobilization 90 days Time to first mobilization
New acute renal failure requiring dialysis 90 days and 1 year New acute renal failure requiring dialysis
Hip re-operation 30 days and 1 year Hip re-operation
Length of hospital stay 90 days Length of hospital stay
New residence in a nursing home 90 days and 1 year New residence in a nursing home
Hospital readmission 90 days and 1 year Hospital readmission
Length of critical care stay 90 days Length of critical care stay
Incisional pain 30 days Incisional pain
Health System Utilization, Long Term Follow up 2, 5, 10 Years Health System Utilization, Long Term Follow up
Sepsis 90 days and 1 year Sepsis
Nonfatal cardiac arrest 30 days and 1 year Nonfatal cardiac arrest
Trial Locations
- Locations (68)
Regional Medical Center of San Jose
🇺🇸San Jose, California, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
Lahey Hospital and Medical Centre
🇺🇸Burlington, Massachusetts, United States
Tufts Medical Centre
🇺🇸Washington, Massachusetts, United States
Ohio State University Medical Centre
🇺🇸Columbus, Ohio, United States
Cliniques Universitaires Saint-Luc
🇧🇪Woluwe-Saint-Lambert, Belgium
South Health Campus
🇨🇦Calgary, Alberta, Canada
University of Alberta Hospital
🇨🇦Edmonton, Alberta, Canada
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Concordia Hip and Knee Institute
🇨🇦Winnipeg,, Manitoba, Canada
Scroll for more (58 remaining)Regional Medical Center of San Jose🇺🇸San Jose, California, United States