Preventing COVID-19-associated Thrombosis, Coagulopathy and Mortality With Low- and High-dose Anticoagulation: a Multicentric Randomized, Open-label Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 160
- 试验地点
- 4
- 主要终点
- Composite outcome of arterial or venous thrombosis, disseminated intravascular coagulation and all-cause mortality
研究概览
简要总结
The ongoing COVID-19 pandemic affects millions of humans worldwide and has led to thousands of acute medical hospitalizations. There is evidence that hospitalized cases often suffer from an important infection-related coagulopathy and from elevated risks of thrombosis. Anticoagulants may have positive effects here, to reduce the burden of thrombotic disease and the hyperactivity of coagulation, and may also hold beneficial anti-inflammatory effects against sepsis and the development of ARDS.
The investigators hypothesize that high-dose anticoagulants, compared with low-dose anticoagulants, lower the risk of venous and arterial thrombosis, disseminated intravascular coagulation (DIC) and mortality. This open-label controlled trial will randomize hospitalized adults with severe COVID-19 infection to therapeutic anticoagulation vs. thromboprophylaxis during the hospital stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •adult patient with COVID-19 infections, admitted to:
- •an acute non-critical medical ward with admission D-dimer levels >1,000ng/mL, or
- •an acute critical ward (ICU, intermediate care unit)
排除标准
- •ongoing or planned therapeutic anticoagulation for any other indication
- •contra-indication to therapeutic anticoagulation
- •hypersensitivity to heparin
- •personal history of heparin-induced thrombocytopenia
- •suspected or confirmed bacterial endocarditis
- •bleeding events or tendency due to a suspected or confirmed hemostatic bleeding disorder
- •organic lesion prone to bleeding
- •platelet count <50G/L, Hb level <80g/L
- •ongoing or recent (<30 days) major bleeding, ischemic stroke, trauma, surgery
- •use of dual antiplatelet therapy
- •pregnancy
- •bodyweight <40kg or >150kg.
- •end of life care setting
- •unwillingness to consent
- •ongoing participation in a COVID-19 randomized clinical trial testing another therapeutic intervention
研究组 & 干预措施
Therapeutic anticoagulation
Participants will be treated with therapeutic doses of subcutaneous low-molecular-weight heparin (enoxaparin) or intravenous unfractionated heparin, from admission until the end of hospital stay or clinical recovery.
干预措施: Enoxaparin (Drug)
Prophylactic anticoagulation
Participants will be treated with prophylactic doses of subcutaneous low-molecular-weight heparin (enoxaparin) or unfractionated heparin, from admission until the end of hospital stay or clinical recovery. If hospitalized in the intensive care unit, they will receive an augmented thromboprophylaxis regimen as standard of care.
干预措施: Enoxaparin (Drug)
结局指标
主要结局
Composite outcome of arterial or venous thrombosis, disseminated intravascular coagulation and all-cause mortality
时间窗: 30 days
Risk of arterial or venous thrombosis, disseminated intravascular coagulation and all-cause mortality
次要结局
- Sequential organ failure assessment score(30 days)
- Disseminated intravascular coagulation(30 days)
- All-cause mortality(30 days)
- Arterial thrombosis(30 days)
- Venous thromboembolism(30 days)
- Sepsis-induced coagulopathy(30 days)
- Acute respiratory distress syndrome(30 days)
- Durations of hospital stay, ICU stay, ventilation(30 days)
- Clinical deterioration(30 days)
研究者
Marc Blondon
Attending Physician, Angiology
University Hospital, Geneva