Low-molecular-weight Heparin to Prevent Recurrent VTE in Pregnancy: a Randomized Controlled Trial of Two Doses
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 1,110
- 试验地点
- 72
- 主要终点
- Symptomatic confirmed deep venous thrombosis
研究概览
简要总结
This is a randomized-controlled open-label trial comparing two different doses of low-molecular-weight heparin (LMWH) in pregnant patients with a history of previous venous thromboembolism (VTE). Both doses are recommended doses in the 2012 guidelines of the American College of Chest Physicians (ACCP), but it is not known which dose is more efficacious in preventing recurrent venous thromboembolism in pregnancy.
Patients enter the study and will be randomized as soon as a home test confirms pregnancy. LMWH will be administered until 6 weeks postpartum. Follow-up will continue until 3 months postpartum. Patients will be recruited by their treating physician, either an obstetrician or internist.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age: 18 years or older, and;
- •Pregnancy confirmed by urinary pregnancy test, and;
- •Gestational age < 14 weeks, and;
- •Previous objectively confirmed VTE, either unprovoked, in the presence of use of oral contraceptives or estrogen/progestagen use, or related to pregnancy or the postpartum period, or minor risk factors (e.g. long distance travel, minor trauma).
排除标准
- •Previous VTE related to a major provoking risk factor (e.g. surgery, major trauma or plaster cast immobilisation in the 3 months prior to VTE) as the sole risk factor, or;
- •Indication for treatment with therapeutic dose anticoagulant therapy (e.g. treatment of acute VTE; permanent use of therapeutic anticoagulants outside of pregnancy), or;
- •Inability to provide informed consent, or;
- •Any contraindication listed in the local labelling of LMWH.
研究组 & 干预措施
Low dose LMWH
Fixed low dose low-molecular-weight heparin:
- Fixed low dose nadroparin, or;
- Fixed low dose enoxaparin, or;
- Fixed low dose dalteparin, or;
- Fixed low dose tinzaparin.
干预措施: Low dose nadroparin (Drug)
Low dose LMWH
Fixed low dose low-molecular-weight heparin:
- Fixed low dose nadroparin, or;
- Fixed low dose enoxaparin, or;
- Fixed low dose dalteparin, or;
- Fixed low dose tinzaparin.
干预措施: Low dose enoxaparin (Drug)
Low dose LMWH
Fixed low dose low-molecular-weight heparin:
- Fixed low dose nadroparin, or;
- Fixed low dose enoxaparin, or;
- Fixed low dose dalteparin, or;
- Fixed low dose tinzaparin.
干预措施: Low dose dalteparin (Drug)
Low dose LMWH
Fixed low dose low-molecular-weight heparin:
- Fixed low dose nadroparin, or;
- Fixed low dose enoxaparin, or;
- Fixed low dose dalteparin, or;
- Fixed low dose tinzaparin.
干预措施: Fixed low dose tinzaparin (Drug)
Intermediate dose LMWH
Intermediate dose low-molecular-weight heparin. Dosing is weight-adjusted according to the protocol.
- Intermediate dose nadroparin, or;
- Intermediate dose enoxaparin, or;
- Intermediate dose dalteparin, or;
- Intermediate dose tinzaparin.
干预措施: Intermediate dose nadroparin (Drug)
Intermediate dose LMWH
Intermediate dose low-molecular-weight heparin. Dosing is weight-adjusted according to the protocol.
- Intermediate dose nadroparin, or;
- Intermediate dose enoxaparin, or;
- Intermediate dose dalteparin, or;
- Intermediate dose tinzaparin.
干预措施: Intermediate dose enoxaparin (Drug)
Intermediate dose LMWH
Intermediate dose low-molecular-weight heparin. Dosing is weight-adjusted according to the protocol.
- Intermediate dose nadroparin, or;
- Intermediate dose enoxaparin, or;
- Intermediate dose dalteparin, or;
- Intermediate dose tinzaparin.
干预措施: Intermediate dose dalteparin (Drug)
Intermediate dose LMWH
Intermediate dose low-molecular-weight heparin. Dosing is weight-adjusted according to the protocol.
- Intermediate dose nadroparin, or;
- Intermediate dose enoxaparin, or;
- Intermediate dose dalteparin, or;
- Intermediate dose tinzaparin.
干预措施: Intermediate dose tinzaparin (Drug)
结局指标
主要结局
Symptomatic confirmed deep venous thrombosis
时间窗: From date of randomization up to 6 weeks postpartum
All events of symptomatic deep venous thrombosis in subjects will be recorded from the the date of randomization up to 6 weeks postpartum. Definition of symptomatic deep venous thrombosis (DVT): Suspected (recurrent) DVT with one of the following findings: If there were no previous DVT investigations: * Abnormal compression ultrasound (CUS), * An intraluminal filling defect on venography. If there was a previous DVT investigation: * Abnormal CUS where compression had been normal or, if non-compressible during screening, a substantial increase (4 mm or more) in diameter of the thrombus during full compression, * An extension of an intraluminal filling defect, or a new intraluminal filling defect or an extension of non-visualization of veins in the presence of a sudden cut-off on venography.
Symptomatic confirmed pulmonary embolism
时间窗: From date of randomization up to 6 weeks postpartum
All events of symptomatic pulmonary embolism in subjects will be recorded from the the date of randomization up to 6 weeks postpartum. Definition of symptomatic pulmonary embolism (PE): Suspected PE with one of the following findings: * A (new) intraluminal filling defect in subsegmental or more proximal branches on spiral CT scan * A (new) intraluminal filling defect or an extension of an existing defect or a new sudden cut-off of vessels more than 2.5 mm in diameter on the pulmonary angiogram * A (new) perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan (VPLS)
次要结局
- Symptomatic confirmed deep venous thrombosis(From date of randomization up to 3 months postpartum)
- Symptomatic confirmed pulmonary embolism(From date of randomization up to 3 months postpartum)
研究者
S. Middeldorp
prof.dr. S. Middeldorp
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)