HIP Fracture Accelerated Surgical TreaTment And Care tracK (HIP ATTACK) Trial

Study Overview
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Brief Summary
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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).

Official Title
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HIP Fracture Accelerated Surgical TreaTment And Care tracK (HIP ATTACK) Trial

Conditions
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Hip Fractures

Intervention / Treatment
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* Other: Accelerated medical clearance and surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Accelerated medical clearance and surgery<br>Rapid medical clearance with targeted arrival to the operating room within 6 hours of diagnosis of a hip fracture requiring surgical repair. | Other: Accelerated medical clearance and surgery<br>* Rapid medical clearance with targeted arrival to the operating room within 6 hours of diagnosis of a hip fracture requiring surgical repair.<br>|
| No Intervention: Standard surgical care<br>Surgical hip fracture repair according to the standard timing. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite - major perioperative complication | Composite of mortality, nonfatal myocardial infarction, nonfatal pulmonary embolism, nonfatal pneumonia, nonfatal sepsis, nonfatal stroke, and nonfatal life-threatening and major bleeding | 90 days | 
| Mortality | All-cause mortality | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | Death due to all causes | 90 days and 1 year | 
| Vascular mortality | Death due to vascular cause | 90 days and 1 year | 
| Non-vascular mortality | Death due to non-vascular cause | 90 days and 1 year | 
| Myocardial infarction | Myocardial infarction | 90 days and 1 year | 
| Cardiac revascularization procedure | i.e., percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG] surgery | 90 days and 1 year | 
| New congestive heart failure | New congestive heart failure | 90 days and 1 year | 
| New clinically important atrial fibrillation | New clinically important atrial fibrillation | 90 days | 
| Nonfatal cardiac arrest | Nonfatal cardiac arrest | 30 days and 1 year | 
| Stroke | Stroke | 90 days and 1 year | 
| Peripheral arterial thrombosis | Peripheral arterial thrombosis | 90 days and 1 year | 
| Pulmonary embolism | Pulmonary embolism | 90 days and 1 year | 
| Deep venous thrombosis | Deep venous thrombosis | 90 days and 1 year | 
| Pneumonia | Pneumonia | 90 days and 1 year | 
| Sepsis | Sepsis | 90 days and 1 year | 
| Infection | Infection | 90 days | 
| Life-threatening bleeding | Life-threatening bleeding | 90 days | 
| Major bleeding | Major bleeding | 90 days | 
| New acute renal failure requiring dialysis | New acute renal failure requiring dialysis | 90 days and 1 year | 
| Peri-prosthetic fracture | Peri-prosthetic fracture | 90 days and 1 year | 
| Prosthetic hip dislocation | Prosthetic hip dislocation | 90 days and 1 year | 
| Implant failure | Implant failure | 90 days and 1 year | 
| Hip re-operation | Hip re-operation | 30 days and 1 year | 
| Time to first mobilization | Time to first mobilization | 90 days | 
| Length of hospital stay | Length of hospital stay | 90 days | 
| Length of critical care stay | Length of critical care stay | 90 days | 
| Length of rehabilitation stay | Length of rehabilitation stay | 90 days | 
| New residence in a nursing home | New residence in a nursing home | 90 days and 1 year | 
| Functional Independence Measure (FIM™) | Functional Independence Measure (FIM™) | 30 days and 1 year | 
| SF-36 score | SF-36 score | 30 days and 1 year | 
| Delirium within 7 days of randomization | Delirium within 7 days of randomization | 7 days | 
| Hospital readmission | Hospital readmission | 90 days and 1 year | 
| New pressure ulcers | New pressure ulcers | 90 days | 
| Incisional pain | Incisional pain | 30 days | 
| Chronic incisional pain | Chronic incisional pain | 1 year | 
| Acute Kidney Injury | Acute Kidney Injury | 90 Day | 
| Acute Kidney Injury | Acute Kidney Injury | 1 Year | 
| Mortality and Institutionalization status of dependents | Mortality and Institutionalization status of dependents | 30 Days | 
| Mortality and Institutionalization status of dependents | Mortality and Institutionalization status of dependents | 1 Year | 
| Economic Analysis | Economic Analysis | 90 Days and 1 Year | 
| Health System Utilization, Long Term Follow up | Health System Utilization, Long Term Follow up | 2, 5, 10 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perioperative outcomes