Prevention of Postpartum Venous Thromboembolism in Women at Intermediate Risk. An Open-label, Randomized, Controlled Trial Comparing Two Strategies With or Without Pharmacological Thromboprophylaxis
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 2,400
- 试验地点
- 18
- 主要终点
- Symptomatic VTE (DVT or non-fatal or fatal PE)
研究概览
简要总结
Venous thromboembolism (VTE) is currently the second cause of death in women of reproductive age worldwide. The incidence of VTE during pregnancy is 1.2 to 1.4/1000 women, half of VTE occurring during postpartum and as PE in majority of cases, accounting for 8.8% of maternal deaths.
Majority of postpartum VTE occurs in women with one or more moderate risk factors (obesity, caesarean section, postpartum hemorrhage). For these women at intermediate risk, the efficacy and safety of thromboprophylaxis have not been assessed yet during postpartum and international guidelines for pharmacological thromboprophylaxis, based on data extrapolated from other populations, observational studies and small clinical trials are inconsistent across countries.
We designed an open-label, randomized, controlled trial, aiming to demonstrate the superiority of a pharmacological thromboprophylaxis strategy with LMWH (LMWH type chosen according to physician / patient's preference) during 6 weeks after delivery (the 6-weeks follow-up visit being matched with usual care) in women at intermediate risk, over no pharmacological thromboprophylaxis.
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)
盲法说明
All critical events (VTE, bleeding and mortality) will be validated by a central, independent clinical events committee (ICEC) which will adjudicate outcomes blinded for treatment allocation (PROBE study).
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women at intermediate risk of VTE during post-partum= with a 3% or more risk of VTE based on a validated prediction model* or International guidelines (ACCP 2012).
- •Age over 18 years
- •Delivery between 6 hours and < 36 hours
- •Written informed consent
- •Definition: Intermediate risk is defined as ≥ 3%, based on risk prediction model developed by Sultan et al taking in account: smoking, varicose veins, obesity, comorbidities, diabetes, pre-eclampsia, post-partum hemorrhage, postpartum infection, emergency or elective section or following ACCP guidelines: one major risk factor or two minor risk factors.
排除标准
- •Previous personal history of VTE
- •LMWH started during antenatal period
- •Need for anticoagulation at curative dose
- •Contraindication to LMWH (previous heparin induced thrombopenia, hemostatic impairment, known severe renal insufficiency)
- •Women who received more than two doses of LMWH since delivery
- •Unable or refusal to give informed consent
- •Aspirin at a daily dose 100 mg or dual antiplatelet therapy
- •Previous inclusion in Mum-VTE study
- •Concomitant participation in another therapeutic study
研究组 & 干预措施
Experimental Group
Pharmacological thromboprophylaxis using LMWH at preventive dosage. The choice of subcutaneous LMWH depends on the practice of each center:
- Enoxaparine 4000 UI (weight > 90 kg 6000 UI)
- Tinzaparine 3500 UI (weight > 90 kg 4500 UI)
- Dalteparine 5000 UI (weight > 90 kg 7500 UI)
- Nadroparine 2850 UI (weight > 90 kg 3800 UI).
All patients can have compression stockings
干预措施: Low molecular weight heparin (Drug)
Control group
No pharmacological thromboprophylaxis. All patients can have compression stockings.
结局指标
主要结局
Symptomatic VTE (DVT or non-fatal or fatal PE)
时间窗: 6 weeks
Blindly adjudicated objectively confirmed symptomatic VTE (DVT or non-fatal or fatal PE) ) during the first 6-week postpartum period
次要结局
- Objectively confirmed symptomatic VTE (DVT or non-fatal or fatal PE)(6 weeks)
- Mortality(3 months)
- Symptomatic VTE (DVT or non-fatal or fatal PE)(3 months)
- Major bleeding (as defined by the criteria of the International Society of Thrombosis and Haemostasis)(3 months)
- Net Clinical benefit(3 months)
- Clinically relevant non-major bleeding(3 months)
- Number of Thrombocytopenia(6 weeks)
- VTE suspicion(3 months)
- Treatment compliance(6 weeks)
- Mortality(6 weeks)
- Major bleeding (as defined by the criteria of the International Society of Thrombosis and Haemostasis)(6 weeks)
- Clinically relevant non-major bleeding(6 weeks)
- Net Clinical benefit(6 weeks)
- VTE suspicion(6 weeks)