HIP Fracture Accelerated Surgical TreaTment And Care tracK (HIP ATTACK) Trial - Feasibility Pilot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 6
- 主要终点
- Feasibility
研究概览
简要总结
There is preliminary evidence that suggests early surgical treatment of a hip fracture may improve patients' outcomes. The investigators propose to do a pilot randomized controlled trial (RCT) to assess the feasibility of a large RCT comparing accelerated surgical repair (i.e. surgery within 6 hours of a hip fracture diagnosis) versus standard care (typically surgery after 36-48 hours).
详细描述
Hip fractures have devastating consequences: the 30-day mortality rate for men is 9% and for women is 5%, and the risk of disability is substantial. Even among patients who are community-dwelling prior to their hip fracture, 11% are bed-ridden and 16% are in a long-term care facility after one year.
The trauma associated with a hip fracture results in pain, bleeding, and immobility. These factors initiate inflammatory, hypercoaguable, stress, and catabolic states that can cause medical complications, including death. Proposed mechanisms for increased mortality and morbidity associated with delayed surgery include 1) complications related to a protracted immobilization (e.g. venous thromboembolism, atelectasis and pneumonia, urinary tract infections, pressure ulcers, and muscle mass loss) and 2) increased cardiovascular events.
Delay in surgery may result in protracted immobility and the associated complications, as well as prolonged exposure to the hypercoagulable-inflammatory-sympathetic state which may increase cardiovascular events. Observational data suggests that these mechanisms are indeed important: delayed surgical repair is associated with increased mortality and morbidity after a hip fracture.
A systematic review and meta-analysis of observational studies addressed the impact of timing of surgery on the outcome after hip fracture. Five studies reported adjusted measures for mortality. The pooled estimate, based on 721 deaths in 4,208 patients, suggested that early surgical treatment (i.e. within the cut-off of the individual studies) of hip fractures was associated with a significant reduction in mortality (adjusted risk ratio [RR] 0.81, 95% confidence interval [CI] 0.68-0.96).
It is possible that these observational data substantially underestimates the real potential of early surgery. The reason is that the "early surgery" in these studies occurred within 24, 48 or 72 hours. If surgery could be uniformly undertaken within 6 hours, given the potential benefits of earlier mobilization and minimization of the period of the inflammatory hypercoagulable state, the benefits might be substantially greater. The substantial impact of treatment of acute myocardial infarction (MI) or stroke within hours adds credence to this possibility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •aged ≥ 45 years AND
- •diagnosed during working hours on week days with a hip fracture requiring surgery
- •Exclusion criteria:
- •We will exclude patients based on the following criteria:
- •patients requiring urgent surgery or urgent interventions for another reason (e.g., subdural hematoma, abdominal pathology requiring urgent laparotomy, acute limb ischemia, other fractures or trauma requiring urgent surgery, or necrotising fascitis; PCI; pacemaker-implantation);
- •open hip fracture;
- •patients refusing participation;
- •patients previously enrolled in the study;
- •Therapeutic anticoagulation not induced by warfarin or intravenous heparin.
- •Criteria in which the timeline of the surgery in the accelerated care group (after accelerated medical work-up) are at the discretion of the attending physicians.
- •acute myocardial infarction associated with a mechanical complication (i.e., acute papillary muscle rupture, ventricular septal defect) or ST-elevation MI;
- •cardiac arrest;
- •cardiogenic shock, defined by systemic hypotension and symptoms of organ hypoperfusion (oliguria, change in mental status, cold extremities) that the treating physician believes is due to a low cardiac output state (measurement of cardiac index or pulmonary capillary wedge pressure is not required) or requiring inotropic drugs;
- •frank pulmonary edema that cannot be corrected within 2 hours (i.e. after 2 hours the patient cannot maintain oxygen saturation ≥ 90% in supine position with nasal oxygen or 28% oxygen);
- •respiratory failure requiring mechanical ventilation;
- •known pulmonary artery hypertension (> 80 mm Hg);
- •home oxygen therapy with concomitant non-warfarin full dose anticoagulation or clopidogrel (because regional anesthesia is not possible);
- •presumptive bacteremia on the basis of fever ≥ 39° Celsius or two of the following: a) Temperature >38° Celsius or <35° Celsius; b) WBC >12 or < 4 or >10% immature bands; c) rigors; and d) hypotension with evidence of organ dysfunction;
- •hereditary or acquired coagulopathy that cannot be corrected within 2 hours to a INR < 1.5,
- •thrombocytopenia (platelets < 75) of unknown origin that cannot be corrected within 2 hours or in case of known chronic thrombocytopenia platelets < 50;
- •deep venous thrombosis in the last month requiring implantation of vena-cava filter;
- •acute stroke within 7 days of fracture;
- •subarachnoid hemorrhage within 1 month of fracture;
- •impaired consciousness of unknown origin (Glasgow coma scale < 12);
- •fractures acquired during a seizure in patients without a known history of epilepsy;
- •hyponatremia (< 120 mmol/L) or hypernatremia (> 155 mmol/L) or hyponatremia < 125 mmol/L or hypernatremia >150 mmol/L associated with severe neurological symptoms (impaired consciousness to coma, seizures);
- •hyperkalemia > 5.5 mmol/L with QRS-complex > 120 milliseconds (in patients without known previous QRS-complex > 120 ms) or hypokalemia < 2.8 mmol/L not amenable to correction within 2 hours;
- •known pH < 7.15 not amenable to correction within 2 hours; or
- •indication for acute dialysis.
排除标准
- 未提供
结局指标
主要结局
Feasibility
时间窗: 18 months
Feasibility defined as: * ability to recruit 60 patients in 18 months * ability to achieve arrival in the operating room within 6 hours of diagnosis in \>=80% of the patients randomized to accelerated surgery * ability to achieve accelerated surgery in a timely manner * ability to achieve medical clearance in a timely manner * resource requirements to achieve recruitment and follow up
次要结局
- All-cause mortality(30 days)
- Length of hospital stay(30 days)
- Length of intensive care unit stay(30 days)
- Length of stay in rehabilitation facility(30 days)
- New admission to a long-term care facility(30 days)
- Functional Independence Measure (motor domain)(30 days)
- Short form health survey (SF-36) (acute form)(30 days)
- Delirium(7 days after randomization)
- Pre-operative Myocardial Infarction(30 Days)
- Nonfatal Stroke(30 Days)
- Nonfatal Pneumonia(30 Days)
- Nonfatal Pulmonary Embolism(30 Days)
- Sepsis(30 Days)
- New Congestive Heart Failure(30 Days)
- Nonfatal Cardiac Arrest(30 Days)
- Nonfatal myocardial injury after non cardiac surgery (MINS)(30 Days)
- Composite Endpoint(30 Days)
- Major or Life-threatening Bleeding(30 Days)
研究者
P.J. Devereaux
MD, PhD
Population Health Research Institute