Clinically-Important Venous Thromboembolism Following Lower Extremity Fractures: Epidemiology & Prevention
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 700
- 试验地点
- 26
- 主要终点
- Clinically important venous thromboembolism at 3 months
研究概览
简要总结
It is known that patients who fracture their legs sometimes develop blood clots (known as deep vein thrombosis) in their legs. These clots may cause pain and swelling in the leg or they may detach and travel to the lungs producing shortness of breath, chest pain, and sometimes death. Unfortunately, it is not known how frequently these complications occur after leg fractures, or if the use of a blood thinner medication can effectively and safely prevent these clots. Doctors at hospitals across Canada are conducting a study in which patients who have surgery for leg fractures receive either a once-daily injection of a blood thinner, known as low molecular weight heparin, or a placebo injection for up to 14 days after their fractures. Neither the patients nor the doctors know which patient is on the medication and which patient is on placebo. All patients receive an ultrasound examination of their legs at 2 weeks after surgery to monitor for deep vein thrombosis. In addition, all patients are checked for symptoms of leg or lung clots and any side effects of the medication for 3 months. If the blood thinner is shown to be effective at reducing this complication and documented to be safe and cost-effective in this setting it will be recommended for use in such patients. If, on the other hand, the frequency of deep vein thrombosis is too low to justify the cost or inconvenience of taking this medication, this will also be an important finding.
详细描述
RESEARCH QUESTIONS
- What is the incidence of clinically-important venous thromboembolism (VTE) following surgically-repaired, isolated fractures of the tibia, fibula or ankle?
- In patients with surgically-repaired, isolated fractures of the tibia, fibula or ankle, is simple anticoagulant thromboprophylaxis effective, safe, and cost-effective?
BACKGROUND AND RATIONALE
Isolated below-knee fractures are very common injuries seen in all emergency departments and general hospitals. Venographic studies suggest that the incidence of overall deep vein thrombosis (DVT) following such fractures is in the range of 20-50%. However, the prospective studies that have screened patients with these fractures for DVT are few in number and have methodologic limitations. In addition, most of the thrombi detected are distal and small and, therefore, of uncertain clinical significance. Although patients with leg fractures are at risk for symptomatic DVT, PE, and occasionally fatal PE, there is a paucity of reliable data about the incidence of, and risk factors for, the development of clinically-important VTE following contemporary treatment of these fractures.
Furthermore, data related to thromboprophylaxis in these patients are insufficient to recommend prophylaxis, even in patients whose fractures are managed surgically. There is considerable variation in the use of prophylaxis for such patients across North America; the majority of orthopedic surgeons use no prophylaxis, a small proportion use in-hospital prophylaxis only, and an even smaller proportion use therapeutic levels of anticoagulation until the patient is fully mobile without a cast. The routine use of prophylaxis for patients with below-knee fractures may not be necessary, may be associated with adverse effects related to the prophylaxis, and may not be cost-effective. A methodologically rigorous study is required to address all of the above issues.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 16 years
- •Unilateral or bilateral, closed or open, fractures of the lower extremity distal to the knee including:
- •Isolated fractures of the tibia including tibial plateau, shaft and plafond and medial malleolus
- •Isolated fractures of the fibula including fibular head, fibular diaphysis,distal fibula and lateral malleolus
- •Combined fractures of the tibia and fibula
- •Tibia and/or fibula fractures may be accompanied by fractures of the patella and/or foot as well as ligamentous injuries as long as either the tibia or the fibula is involved
- •Patients must be scheduled to undergo surgery (internal or external fixation) for repair of their fracture during the current admission
排除标准
- •Patients presenting greater than 72 hours after injury
- •Major injury involving other site(s)
- •Lower extremity vascular injury requiring surgical repair
- •Known systemic bleeding disorder or INR > 1.5, aPTT > 40 sec, or platelets < 50 x 109/L at baseline
- •Active, uncontrolled bleeding (as determined by the attending surgeon or delegate)
- •Intracranial or other major bleed in the previous 4 weeks
- •Ongoing need for anticoagulation for other reasons
- •Previous DVT or PE (objectively proven or treated with anticoagulants)
- •Known molecular hypercoagulable state
- •Active cancer
- •Inability to receive contrast dye because of pregnancy, contrast allergy, or renal failure (serum creatinine > 300 mmol/L)
- •Hypersensitivity to heparin or LMWH (including history of HIT)
- •Inability to arrange out-of-hospital study medication administration
- •Anticipated inability to undergo endpoint duplex ultrasound or follow-up (day 14 ± 2, 6 weeks, 3 months)
- •Inability or refusal to provide informed consent· Previous participation in this study
- •Estimated weight less than 40 kg
结局指标
主要结局
Clinically important venous thromboembolism at 3 months
次要结局
- Clinically important VTE during the prophylaxis phase
- Symptomatic VTE (either symptomatic DVT or PE or fatal PE) during the post-prophylaxis phase
- Bleeding
- Cost-effectiveness