Pot-Cast: Thrombosis Prophylaxis During Plaster Cast Lower Leg Immobilisation: Determining the Balance Between Benefits and Risks
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,500
- 试验地点
- 8
- 主要终点
- Symptomatic deep venous thrombosis (DVT)
研究概览
简要总结
Currently, guidelines and clinical practice differ considerably with respect to use of anticoagulant treatment during cast immobilization of the lower leg. Trials that have been carried out were aimed at efficacy only, had small sample sizes and therefore mainly used asymptomatic thrombosis as endpoint. From these trials an overall risk benefit-balance could not be established, hence the current controversy. In the proposed study the investigators will use relevant symptomatic endpoints in a large cohort of patients. Furthermore the investigators will follow subjects with an adverse event for a longer period, during which the investigators will assess the long term sequelae of these events. Lastly, the investigators will determine high risk groups that will benefit most from anticoagulant treatment.
Objective: Comparative effectiveness research to determine cost-effectiveness of two existing policies, i.e. treatment with low molecular weight heparin (LMWH) during lower leg plaster cast immobilization following surgical or conservative treatment. In addition the investigators will investigate personalized prophylaxis based on genetic and acquired risk factors.
详细描述
Background:
Currently, guidelines and clinical practice differ considerably with respect to use of anticoagulant treatment during cast immobilization of the lower leg. Trials that have been carried out were aimed at efficacy only, had small sample sizes and therefore mainly used asymptomatic thrombosis as endpoint. From these trials an overall risk benefit-balance could not be established, hence the current controversy exists. In the proposed study we will use relevant symptomatic endpoints in a large cohort of patients. Furthermore we will follow subjects with an adverse event for a longer period, during which we will assess the long term sequelae of these events. Lastly, we will determine high risk groups that will benefit most from anticoagulant treatment.
Objective:
Comparative effectiveness research to determine cost-effectiveness of an existing healthcare policy, i.e. treatment with low molecular weight heparin (LMWH) during lower leg plaster cast immobilization following surgical or conservative treatment. In addition we will investigate personalized prophylaxis based on genetic and acquired risk factors.
Study Design:
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
- None
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
- •All patients in need of immobilization of the lower leg with a plaster cast (or equivalent of a cast) for a minimum of one week for the following indications:
- •Trauma of the lower leg
- •Surgery of the lower leg followed by lower leg immobilization with a plaster cast
- •Non-traumatic indications
排除标准
- •Contra-indications for LMWH use (recent major bleeding, bleeding disorder, allergy)
- •Pregnancy
- •Pre-existent indication for anticoagulation therapy, either LMWH or vitamin K antagonists.
- •History of venous thromboembolism (indication for anticoagulation therapy for prophylaxis of recurrence)
- •Mental of physical disability to fulfill study requirements
- •Insufficient knowledge of the Dutch language
- •Previous participation in the Pot-(K)Cast study
研究组 & 干预措施
LMWH
750 patients with lower leg cast immobilization will be randomized tot receive treatment with a LMWH.
干预措施: LMWH (Drug)
结局指标
主要结局
Symptomatic deep venous thrombosis (DVT)
时间窗: 3 Months
Symptomatic deep venous thrombosis confirmed with compression ultrasonography
Pulmonary Embolism (PE)
时间窗: 3 months
Fatal or non-fatal pulmonary embolism confirmed with: * an intraluminal filling defect in segmental or more proximal branches on spiral CT scan, or * a perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan, or * detected at autopsy
Major Bleeding
时间窗: 3 months
Major bleeding, defined as: * a fatal bleeding, or * symptomatic bleeding in a critical area or organ, or * extrasurgical site bleeding causing a fall in hemoglobin level of 1.24mmol/L (2.0g/dL) or more, leading to transfusion of one or more units of whole blood or red cells, or * surgical site bleeding that requires a second intervention or a hemarthrosis interfering with rehabilitation, or surgical site bleeding that needs blood suppletion.
次要结局
- Other clinically relevant bleeding(3 months)
- Surgical site infection(3 months)
研究者
Suzanne C. Cannegieter, MD PhD
Study director
Leiden University