Hip Fracture Impact on Vascular Events In Noncardiac Surgery patIents: a cOhort evaluatioN (Hip VISION): Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Total and cause specific mortality in hip fracture patients at 30 days
研究概览
简要总结
Hip VISION (Pilot Study) is a Prospective Observational Cohort Study to evaluate the incidence of overall and cause-specific mortality among consecutive patients aged ≥ 18 years presenting with hip fracture to the Juravinski Hospital of the Hamilton Health Sciences. This pilot study will assess the feasibility of a larger prospective international cohort study. After eligibility has been confirmed and informed consent has been obtained, participants will be registered in the study. Troponin level, complete blood counts and serum creatinine level will be collected at day 1 through day 10 post admission. CAM instrument will be employed at admission and once daily post admission day 1 through day 10. FIM Instrument will be administered within 72 hours of admission to establish pre-fracture functional independence and disability. Patients will be contacted by research personnel by telephone 30 days after study registration.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged ≥ 18 years with hip fractures (i.e. fractures involving the subcapital, femoral neck, or intertrochanteric regions), treated either operatively or non-operatively
- •Mechanism of injury consistent with either:
- •A fall from a standing height or;
- •Another mechanism of injury which, in the clinical judgment of an orthopedic surgeon, would impart the same or less traumatic energy as a fall from a standing height
排除标准
- •Patients with fractures isolated to the proximal femoral shaft, with no involvement of the intertrochanteric, femoral neck, or subcapital region
- •Patients with hip fractures resulting from high energy mechanisms, such as motor vehicle accidents or falls from a substantial height
- •Patient who refuse 30-day or 6-month follow up
- •Patients who refuse to consent either by themselves or through a substitute decision-maker (for patients unable to consent, we will use a deferred consent process, as described below).
结局指标
主要结局
Total and cause specific mortality in hip fracture patients at 30 days
时间窗: 30 days
Major complications within 30 days.
时间窗: 30 days
Composite of vascular mortality, nonfatal MI, nonfatal stroke, nonfatal PE, sepsis, and life-threatening bleeding.
次要结局
- Length of hospital stay(30 days)
- First mobilization(30 days)
- New acute renal failure requiring dialysis(30 days)
- New congestive heart failure(30 days)
- New atrial fibrillation(30 days)
- Nonfatal infection(30 days)
- Nonfatal bleeding(30 days)
- Deep vein thrombosis(30 days)
- FIM (motor function)(30 days)
- Nonfatal myocardial injury after noncardiac surgery(30 days)
- Nonfatal pulmonary embolism(30 days)
- Nonfatal stroke(30 days)
- Implant failure or periprosthetic fracture(30 days)
- Re-operation(30 days)
- Nonfatal myocardial infarction(30 days)
- Nonfatal cardiac arrest(30 days)
- CAM days 1-7 post-op(1-7 days post-op)
- New nursing home residence(30 days)
- Cardiac catheterization(30 days)
- PCI(30 days)
- CABG(30 days)
研究者
P.J. Devereaux
MD, PhD, FRCP(C)
Population Health Research Institute