anti10a Levels in Women Treated With LMWH in the Postpartum Period for Preventing Vein Thrombosis Events: A Comparison of Two Doses
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- clexane dosing method in order to achieve anti 10a level >0.2
研究概览
简要总结
The aim of this study is to compare between anti-10a levels in postpartum women receiving different prophylactic doses of LMWH: one group with LMWH doses adjusted by the women's weight and the second group receiving 1mg/kg to a maximum dose of 120 mg
详细描述
pregnancy and postpartum period are associated with increased risk of thromboembolism. this risk is further increased in women with thrombophilia.
This risk is higher in the postpartum period compared with pregnancy period, especially the risk for pulmonary embolism (PE). The American College Of Obstetrics and Gynecologists, The American college of chest physicians and The Royal College of obstetricians and gynecologists recommend using low molecular weight heparin during the postpartum period in women with thrombophilia and women with risk factor for developing thromboembolism. there is no specific guidelines regarding the best protocol based on the level of anti-10 a.
This study will compare between two protocols based on anti-10a levels.
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
- Female
- 接受健康志愿者
- 是
入选标准
- •postpartum women supposed to receive LMWH according to obstetric indications
排除标准
- •known allergy to clexane
- •active bleeding postpartum
- •thrombocytopenia < 75000
- •recent cerebrovascular accident / transient ischemic attack (<4 weeks)
- •glomerular filtration rate) < 30 ml/min)
- •active liver disease
- •malignant hypertension (systolic > 200 mmHg, diastolic> 120 mmHg)
研究组 & 干预措施
clexane according to weight group
clexane dose adjusted for woman's weight according to: weight < 90 kg - 40mg, 91-130kg - 60 mg, 131-170kg - 80mg, >170kg-100mg.
干预措施: clexane (LMWH) (Drug)
clexane mg per kg
clexane dose of 1mg/kg up to 120 mg
干预措施: clexane (LMWH) (Drug)
结局指标
主要结局
clexane dosing method in order to achieve anti 10a level >0.2
时间窗: 4 hour after the women receive the drug
次要结局
- incidence of anti 10a level of >0.6(4 hour after the women receive the drug)
- incidence of vein thromboembolism(during the six weeks after delivery)
- incidence of bleeding events(during the six weeks after delivery)
研究者
Zohar Nachum
MD
HaEmek Medical Center, Israel