The PARTUM (Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity) Trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 8,805
- 试验地点
- 13
- 主要终点
- Symptomatic VTE
研究概览
简要总结
The goal of the PARTUM trial is to determine if taking low-dose aspirin daily for 6 weeks after delivery is similar (non-inferior) to usual care low-molecular-weight heparin injections to prevent venous thromboembolism (VTE: blood clots in the legs or lungs) for postpartum individuals with VTE risk factors.
详细描述
The PARTUM trial design is a Prospective Randomized Open Blinded End-point (PROBE) non-inferiority trial. Participants with risk factors for venous thromboembolism (VTE) as defined by the inclusion criteria will be identified during pregnancy, labor and delivery, and up to 48 hours after delivery.
Eligible and consenting participants will be randomly assigned to one of two study arms: Low-dose aspirin (75-100mg according to country availability) daily for 42 days post-randomization, or a usual care site-specific low-molecular-weight-heparin (LMWH) regimen with the dose and duration of LMWH determined by the participant's healthcare provider.
Follow-up will occur at 6 weeks and 90 days post-randomization.
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
- 否
入选标准
- •ONE (or more) First Order Criterion:
- •Known inherited thrombophilia diagnosed prior to enrolment, regardless of family history of VTE:
- •i. Heterozygous factor V Leiden, or ii. Heterozygous prothrombin gene variant, or iii. Protein C deficiency, or iv. Protein S deficiency, and/or
- •Antepartum immobilization for ≥7 days. Immobilization is defined as bed rest with 90% of waking hours spent in bed at any time during the antepartum period AND/OR
- •TWO (or more) Second Order Criteria:
- •Pre-pregnancy BMI ≥30 kg/m²
- •Smoking in the current pregnancy or within 3 months prior to pregnancy
- •Previous clinical history of superficial vein thrombosis
- •Preeclampsia
- •Current pregnancy ending in stillbirth (pregnancy loss >20 weeks gestation)
- •Unplanned cesarean delivery (unplanned = not a scheduled cesarean delivery)
- •Small-for-gestational-age infant at time of delivery (<3rd percentile adjusted for gestational age and sex)
- •Peripartum or postpartum infection (symptoms/signs of infection and documented fever and laboratory evidence of infection with positive blood cultures or an elevated white blood cell count based on local laboratory cutoffs)
- •Postpartum hemorrhage (≥1000 mL of blood loss, regardless of delivery mode)
排除标准
- •More than 48 hours since delivery at the time of randomization
- •Received more than 1 dose of LMWH since delivery
- •Need for postpartum LMWH prophylaxis or systemic anticoagulation as judged by their physician and/or local investigator. May include but is not limited to:
- •Documented history of provoked or unprovoked VTE
- •Mechanical heart valve(s)
- •Known antiphospholipid syndrome (APS)
- •Known high-risk inherited thrombophilia i) Antithrombin deficiency, or ii) Homozygous factor V Leiden, or iii) Homozygous prothrombin gene mutation, or iv) More than 1 thrombophilia: any combination of 2 or more: factor V Leiden, prothrombin gene mutation, protein C deficiency, protein S deficiency
- •Need for postpartum ASA as judged by their physician and/or local investigator. May include but is not limited to:
- •Documented history of myocardial infarction
- •Documented history of ischemic stroke or transient ischemic attack (TIA)
- •Active bleeding, excluding normal vaginal bleeding, at the time of randomization
- •Known medical condition as judged by their physician and/or local investigator to be a contraindication to ASA or LMWH including known ASA or LMWH allergy
- •<18 years of age
- •Unable or declined consent
研究组 & 干预措施
Aspirin
Low-dose aspirin (75-100 mg) once daily for 6 weeks.
干预措施: Aspirin (Drug)
Low-molecular-weight heparin
Site-specific low-molecular-weight heparin regimen as prescribed by the treating physician.
干预措施: Low-molecular-weight heparin (Drug)
结局指标
主要结局
Symptomatic VTE
时间窗: 6 weeks
Proximal lower or upper extremity DVT, PE involving segmental or higher arteries or multiple subsegmental arteries, and unusual site \[non-limb\] venous thromboembolism
次要结局
- Late symptomatic VTE(90 days)
- Superficial vein thrombosis(At 6 weeks and at 90 days)
- Single subsegmental pulmonary embolism (SSPE)(At 6 weeks and at 90 days)
- All-cause mortality(At 6 weeks and at 90 days)
- Major bleeding(At 6 weeks and at 90 days)
- Wound hematoma requiring intervention(At 6 weeks and at 90 days)
- Heparin-induced thrombocytopenia(At 6 weeks and at 90 days)
- Symptomatic arterial thromboembolism(At 6 weeks and at 90 days)
- Distal deep vein thrombosis(At 6 weeks and at 90 days)
- Clinically relevant non-major bleeding(At 6 weeks and at 90 days)
- Postpartum preeclampsia(At 6 weeks and at 90 days)