Prophylaxis of Venous Thromboembolism in Patients With a Nonsurgical Fracture of the Lower Extremity Immobilised in a Below-Knee Plaster Cast
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 669
- 试验地点
- 5
- 主要终点
- Primary outcome measure is deep vein trombosis as detected by venous duplex
研究概览
简要总结
Objective:
The purpose of this study is to determine the need for thromboprophylaxis in patients with a fracture of the lower extremity being treated conservatively in a below-knee plaster cast and to assess if both of the two tested prophylactic treatments are effective for this indication.
Hypothesis:
Nadroparine and Fondaparinux are both effective in preventing a thromboembolic event in patients with a nonsurgical fracture of a lower extremity immobilised in a below-knee plaster cast.
详细描述
Study Design:
A prospective, randomised, controlled, single blinded, multi-centre trial.
Intervention:
After meeting the inclusion criteria stated above and obtaining informed consent, patients will be randomly assigned to three groups: one receiving Nadroparine (2850 IE anti-Xa = 0,3 ml, given once daily), one receiving Fondaparinux (2,5 mg = 0,5 ml, given once daily) and one receiving no prophylaxis. These dosages are standard for the use in thromboprophylaxis. The first two groups will be instructed by a trained nurse in subcutaneous self-injection of the medicine and will be given pre-filled disposable syringes for once-daily administration for the duration of immobilisation.
In the light of current scientific knowledge a placebo effect of subcutaneous injections of saline in the control group is implausible since the outcome measure (colour duplex sonography) is an objective one.
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
- Single (Outcomes Assessor)
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
- •at least 18 years
- •with a nonsurgical fracture of the lower extremity requiring immobilisation in a below-knee plaster cast for a minimum of 4 weeks.
排除标准
- •Delay between injury and Emergency Department visit greater than three days
- •Pregnancy/ lactation
- •Body weight < 50 kg
- •Severe hepatic impairment
- •Severe renal impairment (creatinin-clearance < 30 ml/min)
- •Known hypersensitivity to nadroparine or fondaparinux
- •Pre-existing venous thromboembolism
- •Pre-existing post-thrombotic syndrome
- •Documented congenital or acquired bleeding tendency/disorder(s)
- •Active, clinically significant bleeding
- •Clinically significant bleeding within the past six months
- •Previous or active bleeding from the digestive tract by peptic ulcer, tumours, hiatus hernia or diverticulosis
- •Severe hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 110 mmHg)
- •Bacterial endocarditis
- •Haemorrhagic stroke within the previous two months
- •Severe head injury within the previous three months
- •Intraocular, spinal, and/or brain surgery within the previous twelve months
- •Major surgery within the previous two months
- •Treatment with LMWH or other anticoagulants
- •Anticoagulant therapy required or likely to be required during the study period (e.g. planned surgery justifying pharmacological thromboprophylaxis)
研究组 & 干预措施
Nadroparin
Subjects randomized to group receiving nadroparin 0,3 cc daily during immobilization
干预措施: Nadroparin (Drug)
Fondaparinux
Subjects randomized to fondaparinux 2,5 mg daily group during immobilization
干预措施: Fondaparinux (Drug)
结局指标
主要结局
Primary outcome measure is deep vein trombosis as detected by venous duplex
时间窗: subjects are assessed after 6 weeks
次要结局
- Bleeding complications(6 weeks)
研究者
R.J. Derksen
Principal investigator
Red Cross Hospital Beverwijk