HIP Fracture Accelerated Surgical TreaTment And Care tracK (HIP ATTACK) Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3,001
- 试验地点
- 69
- 主要终点
- Composite - major perioperative complication
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥45 years; and
- •diagnosis of hip fracture during working hours with a low-energy mechanism (i.e., falling from standing height) requiring surgery.
排除标准
- •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.
研究组 & 干预措施
Accelerated medical clearance and surgery
Rapid medical clearance with targeted arrival to the operating room within 6 hours of diagnosis of a hip fracture requiring surgical repair.
干预措施: Accelerated medical clearance and surgery (Other)
Standard surgical care
Surgical hip fracture repair according to the standard timing.
结局指标
主要结局
Composite - major perioperative complication
时间窗: 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
时间窗: 90 days
All-cause mortality
次要结局
- SF-36 score(30 days and 1 year)
- Infection(90 days)
- Life-threatening bleeding(90 days)
- Health System Utilization, Long Term Follow up(2, 5, 10 Years)
- 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)
- Pneumonia(90 days and 1 year)
- Hospital readmission(90 days and 1 year)
- Acute Kidney Injury(1 Year)
- Sepsis(90 days and 1 year)
- Major bleeding(90 days)
- Myocardial infarction(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)
- Deep venous thrombosis(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)
- Prosthetic hip dislocation(90 days and 1 year)
- Implant failure(90 days and 1 year)
- Length of rehabilitation stay(90 days)
- Delirium within 7 days of randomization(7 days)
- Chronic incisional pain(1 year)
- Economic Analysis(90 Days and 1 Year)
- Mortality and Institutionalization status of dependents(1 Year)
- Functional Independence Measure (FIM™)(30 days and 1 year)
- New pressure ulcers(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)
- Length of critical care stay(90 days)
- Incisional pain(30 days)
- Acute Kidney Injury(90 Day)
- Mortality and Institutionalization status of dependents(30 Days)